(WB) Studies to 'stop therapy' lack participants

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(WB) Studies to 'stop therapy' lack participants

The Washington Blade Inc. - October 2, 1998
Lisa Keen


While the National Institutes of Health and others plan studies to test the possibility of stopping combination therapy in people with HIV who have been able to drastically reduce their viral loads and maintain them under the level of detection, one practical problem has become paramount: finding participants.

Richard Chaisson, an AIDS researcher at Johns Hopkins University School of Medicine, raised the issue in an online presentation last week summarizing, for a Web site sponsored by Healthcare Communications Group, the first day of presentations at the Interscience Conference on Antimicrobial Agents and Chemotherapy. He noted that Massachusetts researcher Bruce Walker, a leading proponent for treating HIV as soon after infection as possible, presented to the ICAAC audience information such about one patient who began treatment before developing HIV antibodies and then stopped therapy. At first, Walker reported, the patient experienced a rebound in his viral load. The patient started taking drugs again and continued them for "a number of months," noted Chaisson's summary, and then stopped therapy again. The second time, Walker told the ICAAC gathering, the patient maintained an undetectable level of virus.

"The patient has now gone 19 months without treatment and has an undetectable viral load," noted Chaisson's summary of Walker's presentation. Because doctors have found "replication-competent virus" still in the patient's CD4 cells, they conclude that the infection is "being controlled by immune responses despite a lack of eradication."

Chaisson reported that Walker stressed that while the experience with the one patient suggested the "very exciting possibility of short-term therapy leading to effective control without therapy," it could be considered only anecdotal. Other research sites trying to study this relatively new theory that therapy can be halted are, said Chaisson, finding it very difficult to find participants.

Even though an estimated 40,000 people are becoming infected with HIV every year in the U.S., noted Chaisson, "In the last year, six sites funded with more than $6 million of NIH grant support to study acute HIV infection have enrolled only a handful of patients."

More kudos for vitamins C and E

A report in the Journal of Clinical Investigation last July suggested that people with HIV who take the nucleoside analog AZT and suffer from nearsightedness as a side effect can avert developing that side effect by taking high doses of vitamins C and E. In the Sept. 10 issue of the medical journal AIDS, researchers at the University of Toronto have more good news about vitamin C and E supplements. They say vitamins C and E can "produce a trend towards a reduction in HIV viral load."

In the latest study of 40 patients, one group received 800 IUs of Vitamin E and 1000mg of Vitamin C per day; the other group received placebo. While all the patients were on combination therapies, the study was conducted before the widespread use of protease inhibitors and none of the 40 was on protease inhibitors.

According to the researchers, after three months, the group taking the vitamin supplements had a "more favorable" decrease in viral load than the group on placebo.

In brief ...

NEW NUKE ON HORIZON: National Institutes of Health researcher Robert Yarchoan told a gathering of AIDS researchers in Baltimore last month that a new nucleoside analog called F-ddA is showing signs of success in fighting HIV and that the virus is slow to develop resistance to the drug. The National Cancer Institute, he said, is currently testing its effectiveness in combination with other antivirals.

ORAL INTERFERON: An international multi-center study of interferon in an oral format (the drug is currently available only through intravenous injections) reported in the September Journal of Infectious Diseases that the oral dosing may be a viable option. Interferon, in combination with other antivirals, is considered one of the strongest hopes for eliminating HIV within the immune system's hidden reservoirs.

TB PREVENTION URGED: Researchers in South Africa and England reported in the current British Medical Journal that preventive treatment against tuberculosis for only three to 12 months protects people with HIV against the dangerous respiratory infection, especially those people who have a positive tuberculin skin test. The study was conducted in the United States and three other countries on more than 4,000 people with HIV and used a variety of preventive treatments.

CONCENTRATED PROTEASE: A study from the Netherlands reported in the July 30 issue of the journal AIDS that higher levels of protease inhibitors in the blood mean higher rates of clearing the virus from the blood. The study involved 39 patients on a four-drug regimen of two protease inhibitors (saquinavir and nelfinavir) and two nucleosides (d4T and 3TC). Patients with higher levels of protease inhibitors in their blood saw their viral loads drop more quickly.
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