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Issue #184: July 5, 1998
fastfax is available by fax in the 215 and 610 area codes at no cost, or by mail anywhere for $20.00 per year, by calling 215-545-6868, and by E-mail by contacting and type the message SUBSCRIBE in the message section. Sources for some articles in this issue include PR Newswire and Reuters .Committee seeks $637g cut for city AIDS programs
HIV strain that resists treatment found
Lower HAART dosages show promise
Study shows NNRTI effective for kids
Immunity recovery trends reported
Geneva hears report on resurgent virus study
FIGHT seeks counselor for vaccine trial
Shift of funds to suburban areas sought
Committee seeks $637g cut for city AIDS programs
The Care Committee of the Philadelphia HIV Commission has announced it will ask the Philadelphia Health Department to reduce current funding for AIDS services in Philadelphia by about $637,000 -- a cut that would dramatically reduce AIDS services in the neighborhoods where the epidemic is having its most deadly impact.The cut would be concentrated in "practical" services for people living with HIV/AIDS, such as emergency financial assistance, food programs, home health services, housing, complementary therapies, etc. The cut, amounting to 10% of the total funding for the service areas, would also impact on "system-wide coordination" activities such as quality assurance, information and referral, and planning and administrative functions.
Responding to complaints from providers and advocates from the Philadelphia suburban counties and southern New Jersey, the Committee is recommending that the proportion of Ryan White CARE Act Title I funding allocated to Philadelphia-based AIDS service organizations be reduced from 76% of the total pool of funds to only 70%, with the remaining amounts split evenly between providers in suburban southeastern Pennsylvania and the four southernmost counties of South Jersey.
Rick Britt, co-chair of the Care Committee, which develops priorities for allocation of the Title I funding, told Philadelphia representatives to the Commission on July 1st that he did not consider the recommendation debatable since the full HIV Commission had recommended the allocation percentages last year, even though actual allocations of Title I funding were not made in accordance with that formula.
Title I funding is awarded by the federal Health Resources and Services Administration (HRSA) to local metropolitan areas to support direct care services to people living with HIV/AIDS. Title I funding cannot be used for AIDS education or prevention activities. The HIV Commission is a regional "planning council" mandated under the CARE Act to recommend priorities for the use of Title I funding to local grantees -- in Philadelphia, the grantee is the Philadelphia Dept. of Public Health.
Other Commission members said that despite Britt's contention that the Care Committee recommendation could not be overturned, the full HIV Commission has the authority to change it at a final recommendation meeting to be held on July 22nd.
It is unclear why the 70-15-15 split was not implemented this year by the city's AIDS Activities Coordinating Office (AACO), which administers the Title I funds for the city health department. Sources said that AACO is unwilling to make major cuts in city AIDS services solely on the basis of a mathematical calculation. Additionally, city officials have routinely pointed out that Title I funding, under federal law, is mandated to support services for low-income and uninsured people with AIDS, who are believed to me more predominant in the city than in the suburban areas.
The funding shift would likely have a serious impact on the ability of Philadelphia's overburdened AIDS system to maintain current levels of care for people with HIV/AIDS in the city. It would not effect current funding levels for the three top priorities for the region -- primary medical care, case management, and medications.
According to the latest AIDS surveillance report issued by AACO, almost 77% of AIDS cases diagnosed over the last 12 months have been located in the city. South Jersey had 12.5% of the total cases over the last 12 months, with the four Philadelphia suburban counties comprising 11.5%.
Since 1981, when AIDS first became a reportable disease in the region, the city has experienced almost 72% of cases. More than half (54.6%) of people diagnosed with AIDS since 1981 have died. In recent years, the city's proportion of new AIDS cases has consistently crept up while cases in the other eight counties in the region have slowly decreased.
AACO co-director Patricia Bass, who oversees the Title I process for the city, was unavailable for comment because she is on vacation. Sources said, however, that AACO has seen the regional percentage allocation formula as an overall guideline for distributing federal AIDS funds rather than a formal requirement, and that in the end, actual funding decisions are made on the basis of where Title I services are most needed and where the highest concentrations of uninsured people living with HIV/AIDS seek services. Others noted that many suburban PWAs routinely seek their medical and social services in the city even though they actually live in suburban areas, especially those who live in Camden, Delaware and Montgomery counties.
One Commission member, who asked not to be identified because of fear of retaliation, said that the percentage split pushed by the Care Committee was "provider-driven" and "aimed at getting money to people who want to keep their jobs, rather than to the people who most need help."
"Splitting the money on the basis of where organizations are based is an artificial formula that has nothing to do with the realities of people with AIDS," this Commission member said. "It's hard work to try to put the money where it can do the most good, but that's what we're here to do. These kinds of automatic formulas are quick-fixes that make it easier to be a Commissioner, but harder for people with AIDS to get the help they need to stay alive."
The HIV Commission priority-setting process has become increasingly combative in recent weeks. A chorus of criticism has come down on Commission and AACO staff on issues ranging from what some claim as violations of the Commission's approved planning process and the failure of AACO and the Commission to provide the basic information needed by Commission members to develop their recommendations.
Commission planning staff has told Commission members that they are unwilling to include recommendations for funding priorities developed by most of the Commission's formal caucuses -- which represent ethnic groupings, women and HIV+ consumers -- because they have decided that the caucuses were either not adequately representative or included too few participants. Critics have countered that the Commission adopted two years ago a process through which most of the basic recommendations for funding would generate from the ethnic and special caucuses, and that Commission staff has ignored that provision.
Others have complained that neither the Commission nor AACO have been able to provide data on current utilization of services or unit costs of services, as demanded by the Commission to help it determine where best to concentrate the Title I funding.
City officials have expressed concern that the Commission may recommended significantly different funding priorities each year, making it hard to develop consistent HIV services in the region because funding cannot be counted on by providers who are attempting to construct service systems.
Philadelphia Commissioners, meeting on July 1st, developed a set of funding recommendations that call some major changes in how city services are funded next year, and which would likely require yet another competitive funding application process of the type that was seen as a major disruption of AIDS services just a few months ago. As a result of changes in priorities made last year by the Commission, the city was forced to significantly reduce AIDS case management services in the city, especially for organizations concentrating on Latinos, and primary medical care services for uninsured people were also reduced.
The Philadelphia Commission members have also asked for an increase in funding in the area of outreach services, which are aimed at helping HIV+ people who are not receiving AIDS services connect to the AIDS service system. The Philadelphia Commissioners proposed increasing the portion of Title I funding for outreach services from this year's 7.36% to an even 10% of the funding available. City officials have discouraged putting more money in the outreach category, claiming that the services have not shown themselves to be particularly effective in bringing new people into services and have become, in effect, basic AIDS education services not supportable through Title I funding.
"Consumers should not be held hostage to AACO's inability to implement this program according to definitions that actually will help people get into care," said Michael Hinson, a Commission member.
Others have severely criticized AACO for its management of the outreach project, noting that the agency has changed the regulations and expectations for the projects receiving outreach funding three times in the past eighteen months, and set burdensome reporting requirements that are unrealistic for the agencies that provide the outreach services. The debate is particularly important since most analyses indicate that only about a third of the 21,000 people thought to be living with HIV infection in the region are actually participating in the AIDS service continuum supported by Title I and other public AIDS funding.
Other areas which have led to disputes between AACO and the Commission planning council include a recommendation from the Philadelphia Commissioners that the proportion of Title I funding that AACO can use for its own administrative costs be reduced from the current level of 5% -- the maximum allowed under the Ryan White Act -- to only 4.26%. Some city sources have indicated that if AACO has less money to administer the Title I program, it may withdraw as the grantee, which would require either another county to be willing to take on the grantee responsibilities or the creation of yet another central AIDS agency to oversee the funds. City officials are also concerned that "hobbling" AACO as the grantee will likely result in a major reduction in Title I funding for the region by HRSA, which several years ago eliminated all Title I funding for one major metropolitan because of a similar dispute.
While reducing the administrative allocation for AACO, Philadelphia Commission members have proposed increasing the funding available for administration of the HIV Commission itself, from 3.42% to 3.7%.
Commission members have also expressed concern at AACO's decision to put funding for "psycho-social" services -- which includes mental health and substance abuse treatment services for people with AIDS -- in the city's behavioral health Medicaid program, called Community Behavioral Health (CBH). They charge that giving CBH the funding has not resulted in more or better care for people with HIV/AIDS in need of psycho-social services, and that in any case the city receives over $300 million from the state every year to cover the cost of behavioral health care for uninsured people. Most Commission members have advocated for using the funding for psycho-social services -- which last year approached $460,000 but which they recommend be reduced to about $140,000 next year -- to support specialized behavioral health programs for uninsured people with AIDS, rather than simply "thrown in" to the multi-million dollar pool CBH has available for uninsured care.
Other areas of dispute include the allocation for "minority community capacity-building," which Philadelphia Commissioners have asked be cut from 3.15% to 2%, and for which the city has not presented a plan of action since the collapse of the Minority AIDS Project of Philadelphia (MAPP) last year. MAPP formally closed its doors on June 30th.
HIV strain that resists treatment found
The case of San Francisco person with HIV whose viral strain appears to be resistant to existing AIDS therapies dominated discussed at the 12th International AIDS Conference, which was held in Geneva, Switzerland in late June.If the case indicates that HIV is mutating to protect itself from highly-active anti-retroviral therapies -- HAART, the drug combinations which have offered the most hope to people with AIDS that the disease will not ultimately kill them -- it's "everybody's worst nightmare," one researcher said.
University of California/San Francisco clinicians reported at the conference that HIV resistant to multiple reverse transcriptase and protease inhibitors was transmitted to this individual with no history of antiretroviral therapy.
A detailed report on he case is to be published in The New England Journal of Medicine in July, and the authors are concerned that transmission of protease inhibitor-resistant HIV could signal "...an important emerging clinical and public health problem."
The investigators who reported the case, Drs. Frederick M. Hecht and James O. Kahn of the UCSF-Options Primary HIV Project, made the discovery during an assessment of drug resistance in 48 individuals who had recently seroconverted and had no history of antiretroviral therapy.
Drs. Hecht and Kahn assessed drug resistance in this cohort using "...genotypic analysis of plasma HIV-1 RNA," according to a draft of the upcoming journal article. They note that, in the case under study, "...genotypic mutational pattern likely represent[ed] resistance to AZT, 3TC, indinavir, ritonavir, saquinavir and nelfinavir," according to a meeting abstract. The six drugs are the primary treatments used by people with HIV/AIDS.
The case subject "...responded well to three drugs," Dr. Kahn said. "But his viral load decay was much slower than what we've seen with other similarly infected people with primary infection. When we went back and looked at his resistance patterns, we were shocked to see that he was resistant to reverse transcriptase and protease, and, when his source for the infection was identified, we saw that the source patient had the same patterns of resistance."
A similar case was reported in Geneva by Dr. Sabine Yerly and associates at University Hospital in Geneva. Dr. Hecht said that the Swiss group detected AZT-resistant mutations in 5 of 67 individuals with primary HIV infection. In that cohort, one individual, according to a meeting abstract, had "...mutations associated with 3TC, ddC and nevirapine resistance."
Dr. Hecht also thinks the Swiss group has identified a second, as yet unreported, case of protease-inhibitor virus transmission to a treatment-naive patient. "That's the only other group that I'm aware of that's reporting this," he said.
"In a sense, this is everybody's worst nightmare," Dr. Kahn said. "A multiple-drug resistant virus right from the start. We think that that might indicate poor response to therapy, perhaps a more rapid viral replication and a more rapid decline in CD4 cells and a rapid progression to disease or even death. We're very concerned about trying to contain this and to get some perspective on this."
"We still don't know how frequently resistant strains are transmitted," said Dr. Hecht. "But we now know that people can acquire strains with multidrug resistance, including resistance to protease inhibitor treatment."
The study team assessed drug resistance in a group of HIV-positive patients who had never been treated with antiretroviral agents, and found that the one man carried a strain of HIV that was resistant to 6 of the 11 approved HIV antiretroviral drugs.
According to a UCSF press release, the patient reported that he had had receptive anal intercourse without a condom in the 6 months prior to being diagnosed. The patient reported that his partner had withdrawn before ejaculation, "a behavior that many in the gay community have considered to be a low-risk practice," notes the statement.
Further investigation revealed that the patient's partner was HIV-positive, and had been "sporadically treated" with nine antiretroviral drugs, according to the press release. Hecht explained that interruptions in treatment may have led to the development of the resistant HIV strain that was transmitted to the patient.
"There may be a tendency to feel complacent because of the success of treatment efforts," said Hecht, "but the fact that this transmission occurred by a practice that many consider to be 'safe' highlights the crucial role of continued prevention efforts needed to control the HIV epidemic."
The patient has "responded well to three drugs," Kahn said. It is clear that the patient's partner "transmitted a resistant isolate, and that resistant isolate took hold, and though the reported case did respond to therapy, it was a much slower response," he added.
Kahn stressed the need for HIV-positive patients to take their antiretroviral drugs. "It's the intermittent use, or incomplete use, or the poorly adhered to medication regimen that leads to resistance, and as proteases become a more common treatment paradigm, I'm afraid that there will be an increase in resistance in the community and perhaps the spread of resistant virus to new people," Kahn said.
Dr. Margaret Chesney, professor of medicine at UCSF and a co-author of the study, said in a press statement that, "The bottom line is that helping patients stick to these difficult regimens is as important as the drugs themselves."
Meanwhile, Dr. Anthony Fauci of the National Institutes of Health presented an overview of the state of HIV treatment at a press conference. Taken together, the data presented in Geneva on the efficacy and toxicities associated with triple combination therapies, he said, provide us with "sobering news about the reality of where we are right now."
Dr. Fauci told a packed house of reporters, "I don't think you can say that this conference is saying that all the news is bad for combination therapy. But there is a lot more to do." And there is another hurdle to overcome. "The thought of keeping people on therapy for 10 or 15 years is something that is a very difficult concept to swallow because of the mounting toxicities. Therefore, we need to address the issues of how we are going to tackle this."
Dr. Fauci also addressed the issue of an effective AIDS vaccine. He noted that President Clinton has called on the AIDS research community to have an effective vaccine for HIV by the 10 year mark. "We are 1 year into it and that leaves 9 and I don't think that is such a tall order."
Adherence issues debated
In a related discussion indicating the difficult time many people have maintaining treatment regimens, researchers from the Centers of Disease Control and Prevention reported that 36% of healthcare workers occupationally exposed to HIV are unable to complete a course of postexposure prophylaxis.
Dr. Helene Gayle told meeting attendees that 75% of healthcare workers named adverse effects as the reason that they could not complete PEP.
Fatigue and nausea were most often cited. She noted that problems with prophylactic treatment "...demonstrate that medical solutions aren't always the easy answer that we're looking for."
Dr. Gayle said that not only are the drugs poorly tolerated, "they are not 100% effective. The most effective way to protect healthcare workers is to prevent exposure in the first place."
Co-investigator Dr. Adelisa Panlilio, who coordinated the data analysis, remarked that informing healthcare workers prior to the start of postexposure prophylaxis of the possible adverse effects, particularly fatigue and nausea, may help to improve adherence. But she agrees with her colleague, saying that "the difficulties with compliance highlight the need for improved efforts to prevent HIV exposure."
In a separate presentation, Dr. Allyn K. Nakashima described how he and his colleagues at the CDC interviewed more than 1,200 adults with HIV or AIDS in an attempt to identify the characteristics of patients who adhere to antiretroviral regimens, as well as the characteristics of those who do not.
The investigators found that adherence lessened as the duration of treatment increased. Patients were more likely to "always" take their medications if they were not IV drug users, did not have AIDS, and had received their diagnosis or had been taking therapy for less than 2 years, the researchers said.
According to their abstract, the most common reasons for not taking medications as prescribed were "...'forget to take them'...'can't work them into my schedule'...and 'side effects.'" In their abstract, the investigators write: "Dosing schedules and formulations...that will assist patients in adhering to complicated antiretroviral regimens over long periods are urgently needed."
Lower HAART dosages show promise
Agouron Pharmaceuticals, manufacturers of the protease inhibitor Viracept, has announced that the medicine might work with a daily dose of two pills instead of three, and other drug companies are releasing data that shows that lower dosages of their drugs make work as well.Reducing the dosage by even one pill could help more people stick with the complicated regimens that stave off AIDS by combining several of the latest anti-HIV drugs, the company said. Some people with HIV have take 20 pills a day and follow complex rules about what kinds of food they can eat and when they can eat and take pills.
Viracept can be taken with food, making it easier for patients to follow their dosage regimens.
"Adherence with combination therapy is clearly a crucial issue which dramatically affects both clinical outcome and the patient's quality of life," said Steve Schnittman, director of Bristol-Myers Squibb Co.'s infectious disease clinical research, in a statement.
Bristol-Myers said it is studying whether its AIDS drug, Videx can be taken just once a day instead of twice.
And Roche has presented research showing its protease inhibitor, Fortovase, is just as effective when taken twice a day as the three-times-a-day regimen.
In Agouron's European study, patients were randomly selected to get either twice daily doses of Viracept or take the pill three times a day. All patients also continued taking Zerit and 3TC.
Looking at results for 143 patients after 48 weeks, more than 80 percent of the patients in both groups had fewer than 400 copies of HIV per milliliter of blood. This measure has been considered the level for considering the virus undetectable, although new more sensitive tests can measure even smaller concentrations of the virus.
Study shows NNRTI effective for kids
In preliminary results from a landmark study of heavily pre-treated children with HIV, 49 percent of patients from 90 days to 12 years of age who were treated with Glaxo's investigational drug Ziagen (abacavir), plus Epivir (lamivudine; 3TC) and Retrovir(R) (zidovudine; AZT), had virus levels in their plasma fall below 10,000 copies after 16 weeks of treatment.By comparison, only 35 percent of those patients randomized to receive Epivir+Retrovir had virus levels in their plasma drop below 10,000 copies.
The results were presented at the 12th World AIDS Conference in Geneva.
In addition, 13 percent (13 of 102) of patients in the arm containing Ziagen had virus levels fall below the limits of detection (less than 400 copies/mL of plasma) compared to two percent (two of 103) of patients in the arm receiving Epivir+Retrovir.
The trial represents the first large, well-controlled study of the safety and efficacy of an investigational anti-HIV drug in children. The study will be the first pediatric trial to be used as a basis (along with a trial of Ziagen in adults) for a request for approval of an antiretroviral drug from the U.S. Food and Drug Administration.
The trial represents the first time that children living with HIV/AIDS have been brought into the mainstream of clinical research that investigates new treatments for the disease, according to a Glaxo press release. The effectiveness of most new treatments are not evaluated in children until years after their effect has been proven in adults.
"The early results from this trial suggest that Ziagen will benefit HIV-infected children who have received prior antiretroviral therapy," said Russell Van Dyke, M.D., the study's principal investigator. "Perhaps as importantly, it sets a precedent by including children in the initial clinical development of a new antiretroviral agent.
Pediatricians have long been frustrated by the delay in making new agents available for children.
Clinical trials evaluating treatments for children with HIV differ significantly from those involving adults. Pediatric trials must take into account such things as significant variability in viral replication and CD4 cell counts during the first few years of life, immature immune systems which may not be effective in fighting the virus and may lead to rapid disease progression and the potentially different way drugs are metabolized and excreted in children. As a consequence, the benchmarks used to assess efficacy may differ from those used in trials involving adults. Nevertheless, the conclusion that Ziagen is effective for patients with prior antiretroviral therapy applies to patients of all ages, Glaxo said.
Ziagen, like Epivir and Retrovir, belongs to a drug class known as non-nucleoside analogue reverse transcriptase inhibitors. Ziagen has been formulated as a strawberry/banana flavored liquid for use in children, which is being dosed at 8mg/kg of body weight twice daily. The liquid can also be used for adults who cannot take solid dosage forms. Ziagen is dosed as a 300 mg tablet for adults.
Ziagen was generally well tolerated in the study with the most commonly reported side effects consisting of nausea/vomiting, respiratory tract infections, cough, fever and chills, diarrhea, headache and nasal signs and symptoms. Of these events, only nausea and vomiting were more common in the Ziagen triple combination group compared to the Epivir+Retrovir group.
Also, two patients (two percent) experienced a hypersensitivity reaction consisting of fever with nausea and/or malaise and, possibly, an accompanying rash. Symptoms of this reaction generally occur from between several days to six weeks after initiating therapy and resolve following discontinuation of Ziagen. Patients experiencing this reaction must not take Ziagen again as restarting the drug after a hypersensitivity reaction has resulted in cases of a life-threatening, and in one instance fatal, reaction.
Ziagen is currently available through an open-label program to children under 13 years of age who are no longer maintaining viral suppression with their current treatments.
Immunity recovery trends reported
In the first-ever head-to-head trial comparing two HIV protease inhibitors, six-month data show Fortovase (saquinavir) has a significantly increased rate of CD4 recovery compared to Crixivan (indinavir), in spite of an equal reduction in viral load, when either drug is taken with AZT and 3TC.The data, which were presented at the 12th World AIDS Conference, once again point to the need to understand the significance of immune recovery in people with HIV.
"The increase in CD4 cells in the Fortovase arm is persistently greater than in the Crixivan arm," said Jan Borleffs, M.D., Ph.D., of the University Hospital at Utrecht, The Netherlands, and lead investigator of a comparative trial in people with HIV evaluating the efficacy and safety of saquinavir enhanced oral formulation and indinavir given as part of a triple therapy. "We need to investigate this trend to understand why one protease inhibitor could have an increased rate of CD4 return when producing an equal reduction in viral load to another."
Data from patients that have reached the six-month mark in the study show that the CD4 count in the Fortovase arm increased by 177 cells over baseline (297 cells/uL), while the CD4 count in the Crixivan arm increased by 93 cells over baseline (307 cells/uL).
HIV-RNA levels dropped to below the limit of detection (BLD) in over 85 percent of patients in both arms using both the Roche Amplicor assay (BLD<400 copies/uL) and the ultra sensitive assay (BLD<50 copies/uL). Also presented at the AIDS conference were 48-week data from the Fortovase activity study in which, using an on-treatment analysis, 78 percent of patients (n=65) taking Fortovase plus two nucleoside analogues experienced viral load reductions to below the limit of detection (BLD <400 copies/uL).
When using the ultrasensitive assay (BLD <50 copies/uL), seventy percent of patients (n=66) on this combination had viral load reductions to below the limit of detection at 48 weeks. Fortovase patients had a mean baseline viral load of 65,000 copies/uL and a mean CD4 count of 448 cells.
Geneva hears report on resurgent virus study
Fifty-five percent people with HIV who had achieved undetectable levels of the virus with combination antiretroviral therapy are projected to experience a resurgence of the virus within one year, according to San Francisco AIDS specialists.Results of a community-based study were reported at the 12th World AIDS Conference, and had also been reported in the news media earlier this year. The study was a combined project of the University of California San Francisco and the Community Consortium, an association of 200 health care providers who care for the majority of people with HIV/AIDS in the San Francisco Bay Area.
Though a majority of the 233 patients in the study experienced a breakthrough, or a return of the virus to a detectable level, the patients remained generally healthy, with only three suffering from a significant HIV-related opportunistic infection or malignancy during an average of 10 months of follow-up, said lead author John Nienow, MD, UCSF assistant clinical professor of medicine.
"It's good news that the vast majority of patients are doing well clinically, though over one-half had a resurgence in their viral load,"Nienow said. "What is surprising is that, so far, many of the viral load breakthroughs have not been very high and we have seen very little progression of HIV disease.
"These findings suggest that maintaining undetectable viral load levels may not be necessary to sustain wellness. Loss of viral suppression doesn't appear to lead automatically to clinical progression of disease."
The patients, treated at 10 sites in the Bay Area, were mostly men and 36 percent were minorities. Five individuals had a history of injection drug use. Fifty-five percent of the patients had a diagnosis of AIDS and 51 percent had fewer than 200 T-cells at the start of the study. Thirty-nine percent of the patients had never received any antiretroviral treatment before beginning combination therapy.
All of the patients had viral loads that became undetectable (below 500 copies per milliliter, using branched-chain DNA technology) as a result of having initiated antiretroviral combination therapy or having switched to a new regimen within the previous three months. About three-quarters of the patients had been placed on a three-drug regimen that included a protease inhibitor.
The researchers did not intervene in the patients' therapy or check on their compliance with the prescribed treatment but simply followed their progress, recording their viral load test results and T-cell counts every four months. They also monitored the patients to see if they developed any AIDS-defining illness during the study period.
After an average follow-up of 10 months, the median viral load at return to delectability in the study population was 2,932 copies per millilitre, still considered relatively low, Nienow said.
"One of the interesting findings is that if people break through, they may do so at a low level, which may have significance in terms of clinical progression," he added. "It has been my experience that patients on therapy who break through at low levels remain at low levels and stay well."
The researchers looked at various factors -- including T-cell counts, treatment histories and the number of prescribed drugs in a regimen -- that might predict which patients would experience a breakthrough. The only factor that appeared to be relevant was the patients' viral load before they achieved an undetectable level, he said.
Those patients who had higher viral loads before starting combination therapy that resulted in an undetectable viral load were more likely to experience a return to delectability than those with lower viral loads, Nienow said.
A number of factors have been associated with a return to detectable viral load, including the development of drug-resistant strains of HIV, non-adherence to therapy and length of infection -- none of which could be assessed in this study.
"We don't yet have a clear picture of how relatively low levels of detectable viral load impact progression of disease," he said. "Breakthrough viral load is often recommended as a reason to change treatment, when more clinical predictors may now need to be taken into account.
"We may need to raise the viral load level at which we make decisions to change treatment. If we use very low levels of detectable viral load as an indicator of treatment failure, we may be switching people from clinically successful regimens prematurely, thus depriving them of treatment options they may need in the future."
FIGHT seeks counselor for vaccine trial
Philadelphia FIGHT, which is conducting the first HIV vaccine trial in humans testing the AIDSVAX vaccine, is seek a Risk Reduction Counselor who will help trial participants maintain behaviors that lower their risk for HIV infection.FIGHT says that because there is no guarantee that the vaccine will be effective, and because one-third of the trial participants will receive a placebo rather than the real vaccine, it is imperative that trial participants not believe that they can have unprotected sex or put themselves otherwise at risk of HIV infection because they think the vaccine will protect them.
FIGHT is looking for a full-time counselor with a bachelor's degree or equivalent, experience in risk reduction counseling in this region, and a willingness to work in a research context. Responsibilities include providing pre-test and post-test counseling to volunteers enrolled in the vaccine study, assisting individuals in assessing their personal risk behaviors, and assisting them in developing strategies to minimize or eliminate their own risks.
Salary is negotiable based on qualifications and experience, but is planned on being in the high20's. Fully paid health benefits, dental, vision, short term disability, 3 weeks vacation benefits are included.
To apply, send a resume to Philadelphia FIGHT, 1233 Locust St., Phila. PA. 19107; or fax 215-985-4952; email to fight@fight.org.
FIGHT is also continuing to enroll trial participants, who can determine their eligibility by contacting FIGHT at 215-985-4448 and asking for the AIDSVAX trial.
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