published by We The People Living with AIDS/HIV of the Delaware Valley, Inc.
New TB vaccine could be more effective
Activists win commitment on growth hormone for AIDS wasting
from Critical Path
Food and Drug Administration (FDA) officials have verbally committed to Accelerated Approval for Recombinant Human Growth Hormone (Serostim) for AIDS-associated wasting syndrome.
AIDS activists met with the drug's manufacturer, Serono Laboratories, and the FDA to demand approval on July 24th and 25th. Serono committed at the meeting's conclusion to submitting finalized documents to the FDA early next week.
ACT UP Golden Gate has been monitoring the development of growth hormone for the last five years. Wasting Syndrome, frequently associated with late stage HIV disease, kills 2 of 3 people who die each day in San Francisco of AIDS. Members Jeff Getty and Bill Thorne worked with Tim Horn of the Treatment Activist Group (TAG) to extract the necessary commitments from Serono and the FDA to approve the drug.
"They've finally seen the light of reason. People with AIDS related wasting now will have access to a desperately needed therapy," said Jeff Getty of ACT UP Golden Gate. Members of ACT UP Golden Gate, including Getty, with severe wasting syndrome were able to obtain the drug by participating in clinical trials or through the company's Treatment IND (Investigational New Drug) program. These members have gained 20 pounds or more while taking the drug. Weight gain has translated into an increase in lean body mass, better appetite, and increased energy.
The drug's approval comes after several victories won through ACT UP Golden Gate's work on Growth Hormone. A wholesale price cap of $36,000.00 annually was secured in writing from Serono a few weeks ago, despite the company's original demand of $75,000.00 or more. Although the cap is viewed as an important milestone, the drug's cost will be a problem for cash strapped public assistance programs as addressed by President Clinton this week in San Francisco.
"The importance of the availability of this therapy cannot be underestimated," stated David Mahon of ACT UP Golden Gate, "it's the first approved therapy that is not an appetite stimulant but actually directly effects the metabolic dysfunction of AIDS related wasting syndrome."
ACT UP Golden Gate will continue to scrutinize the situation. For more information, contact ACT UP/Golden Gate, 519 Castro Street #93, San Francisco, CA 94114, phone: (415)252-9200, fax: (415)252-9277, e-mail: actupgg@out.org
TB increases HIV replication
In HIV-infected people who develop active tuberculosis (TB), levels of HIV in the bloodstream increase five- to 160-fold, according to investigators at the National Institute of Allergy and Infectious Diseases (NIAID). The new findings, which build on previous work at NIAID and elsewhere, help explain why HIV-infected people with active TB have a poorer prognosis than HIV-infected people without TB.
Delia Goletti, M.D., Ph.D., of the NIAID Laboratory of Immunoregulation (LIR) and her colleagues report their findings in the Aug. 1 Journal of Immunology.
"Recent research has demonstrated that high levels of HIV in the blood correlate with an increased risk that an HIV-infected person will develop AIDS or die," says LIR Chief and NIAID Director Anthony S. Fauci, M.D. "Our new findings that active TB disease boosts HIV levels in the blood underscore the importance of diagnosing and effectively treating tuberculosis in HIV-infected people."
In addition, adds Dr. Goletti, "These results highlight the importance of preventive TB therapy in HIV-infected people. Such therapy may not only help to control the spread of TB, but also prevent the increased replication of HIV associated with active TB."
The World Health Organization estimates that 5.6 million people worldwide and 80,000 people in the United States are co-infected with HIV and Mycobacterium tuberculosis (M.tb.), the organism that causes TB.
Previously, the NIAID researchers and others have shown in the test tube and in HIV-infected people that immune system activation by stimuli such as opportunistic infections and immunizations boosts the replication of HIV.
"The normal efforts of the immune system to mobilize itself and fight an invader may also result in the increased production of HIV," explains Dr. Fauci. "Chronic immune activation, or the cumulative effect of multiple episodes of immune activation and bursts of virus production, probably contribute to the progression of HIV disease," says Dr. Fauci.
In the current study, the researchers collected blood samples from seven patients with HIV infection and active TB, as well as from seven HIV-infected patients who did not have TB disease but were otherwise similar to the first group of patients.
In patients with TB, the investigators found that the number of HIV RNA copies per cubic millimeter of plasma increased up to 160-fold during the acute stage of TB, compared with levels before the onset of disease and after successful treatment. In two patients for whom anti-TB treatment was not successful -- one patient did not adhere to the TB treatment regimen and one had a drug-resistant strain of TB -- HIV RNA levels did not decrease following treatment.
In the control group of HIV-infected patients (without TB), HIV RNA levels did not change significantly.
In further experiments with two different cell culture systems, the researchers demonstrated that both M.tb. and purified protein derivative (PPD) from the TB organism boosted HIV replication in immune system cells taken from people who tested positive to the PPD test, but not in cells from patients who were PPD-negative. In each system, induction of viral replication correlated with CD4+ T cell activation. The researchers speculate that enhancement of HIV replication likely was due to activation of the specific cells that respond to TB antigens previously "seen" by the immune system.
New TB vaccine could be more effective
A new tuberculosis vaccine made from "naked" DNA might work better with less risk of infection than the vaccine currently given to millions of children worldwide, researchers have announced.
Traditional vaccines, including the one that has been used against tuberculosis for more than 70 years, are often made up of weakened strains of the disease. The traditional tuberculosis vaccine is made from an attenuated form of the disease that infects cows.
But in research chronicled in the journal Nature Medicine, scientists made a new vaccine out of one gene taken from the version of tuberculosis that attacks humans.
"Instead of using an organism ... this simply takes just the gene that can code for the protein for tuberculosis," Margaret Liu, of Merck Research Laboratories, told Reuters Health Service.
The use of just one gene -- known as "naked" DNA -- instead of the many genes contained in tuberculosis DNA shows signs of being as effective as the earlier cow-based vaccine, Liu said.
She said some studies had called into question the effectiveness of the current vaccine. Tuberculosis is considered the most widespread and lethal infectious disease affecting humans.
Even with just one gene from the tuberculosis virus, Liu and other researchers found that vaccinated mice showed immunity to the disease. Trials with humans are a long way off, she said.
Unlike traditional vaccines, which stimulate the human body to produce disease-fighting antibodies, "naked" DNA vaccines are somehow incorporated by the human body's cells and the immune response occurs there.
Another possible advantage to the DNA-based vaccine could be lower risk of infection, Merck researcher Jeffrey Ulmer said, noting that there were rare cases in which the cow-based vaccine caused the disease in humans.
"With the DNA vaccine, because you're not giving the whole organism ... you don't have any chance of having the infection," Ulmer said by telephone from West Point, Pennsylvania.
Merck is also pursuing DNA-based vaccines for AIDS, hepatitis and influenza. Early clinical trials of the influenza vaccine are now in progress.
Boxwood extract shows promise in trials
An extract of the boxwood evergreen tree acts as a natural anti-HIV drug, results of international trials suggest.
In a six-month trial of 332 HIV-infected patients taking the extract, known as SPV-30, 63 percent experienced decreases in the amount of HIV in their blood, reported U.S. study coordinator David Stokes, of Brookline, Mass. Over one-third of the patients experienced a decrease of more than 70 percent, he added.
The extract did not appear to be toxic and few participants reported side effects, he said recently at the XI International Conference on AIDS in Vancouver, British Columbia.
"In addition, nearly half of all participants reported significant increases in energy level and in their overall sense of well-being," Stokes said.
And 44 percent of participants reported that night sweats were less frequent and less severe, he said.
About 60 percent of patients in the study were taking one or more prescription antiviral drugs throughout the study.
The boxwood extract is the only natural product which has been selected by the French Ministry of Health for evaluation as a natural antiviral, according to Stokes. Large-scale trials of the extract have begun at various medical centers in France.
More information about SPV-30 is available from The Health Connection at (800) 783-5050.
Congress will drop HIV ban
Senate and House negotiators reported approval Wednesday of a $265.6 billion defense bill, dropping most controversial provisions in an effort to avoid President Clinton's threatened veto.
The agreement drops an effort to restore the ban on HIV+ people serving in the U.S. military, which was passed by Congress last year by later vetoed by President Clinton. It also eliminates an effort to overturn the President's "don't ask, don't tell" policy on gays in the military, but would still prohibit sale of sex magazines and videotapes on military bases.
Rep. Floyd Spence, chairman of the House National Security Committee, said the negotiators made difficult decisions to write a bill that would not only pass the House and Senate "but can also be signed into law by the president."
"I believe that this bill meets all three tests," the South Carolina Republican said.
Negotiators said they hoped Congress would send Clinton the bill by the end of the week.