NIH may fund HIV trial pushing AIDS drugs


Editor's note: It is astounding that after 25 years of playing in the AIDS sandbox, another study is being done which excludes those who reject antiretrovirals. The NIH is considering a study whose aim it is to change official U.S. recommendations to starting antiretroviral therapy when t-cell counts go below 350 rather than 200, despite mounting concern over the oftentimes debilitating side effects of these drugs.

According to CBS news, "approximately 1 in 4 people with HIV in the U.S. do not know they are infected." The CDC estimates that "252,000--312,000 HIV-infected persons in the United States are unaware of their HIV infection." If this is true, than an equal number are untreated, and a logical deduction would be that a good number of these people are healthy, or they would have sought medical help.

A report coming out of the 2005 Conference on Retroviruses and Opportunistic infections presents these facts based on a study by Eyasu Teshale, MD, a senior service fellow in epidemiology at the Center for Disease Control and Prevention in Atlanta.

"Of the people living with HIV/AIDS in the US, about 212,000 people who should be eligible for antiretroviral drugs are not getting them. Of these individuals:

  • About 42% (89,000 people) are undiagnosed and do not even know they have HIV.
  • About 34% (72,000 people) are receiving care for HIV but are not being prescribed antiretroviral therapy.
  • About 24% (51,000 people) know they are HIV-positive but have not sought medical help.

Clearly there are many who live normal healthy lives and who do not take ARVs. There has been much talk about the "elite controllers" who are being recruited for a new study. These are people who have an HIV positive diagnosis and whose "viral load" is below 1,000. While this is more than has been done in the past, it neglects to address the fact that viral load is not an indicator of AIDS, nor does it account for the thousands of HIV positives who have a "viral load" above 2,000 (another group, Viremic Controllers will also be studied).

Veterans Medical Affairs Researchers To Request NIH Funding for Study Examining Best Time To Start Antiretroviral Treatment
[Jan 08, 2007]

Researchers at the Washington Veterans Affairs Medical Center this month plan to submit a funding proposal to NIH for a study aimed at determining the best time to start antiretroviral therapy, the Washington Post reports.

According to the Post, the study would enroll more than 9,000 adults and children from wealthy and developing countries and would follow participants for five years. Participants each would be randomly assigned to start antiretroviral therapy either soon after HIV transmission or after the virus has begun to significantly affect the immune system, the Post reports. The study "would actually be two studies in one," according to the Post -- one part would enroll participants with CD4+ T cell counts higher than 500 and randomly assign them either to start treatment immediately or to start treatment when their CD4 counts reach the 300 to 350 range. The other part would include participants with lower CD4 counts and assign them either to start immediate treatment or to wait until their CD4 counts reach the 200 to 250 range. "This is like the holy grail of AIDS research," Fred Gordin of the Veterans Affairs Medical Center said, adding, "People pretty much thought it couldn't be studied." Anthony Fauci, head of NIH's National Institute of Allergy and Infectious Diseases, said, "Universally, people feel this is an important question." Many guidelines, including those from the U.S. government and the World Health Organization, recommend that HIV-positive people start treatment when their CD4 counts fall between 350 and 200, and some doctors believe that treatment should start at a count of 500, according to the Post. Although the "pendulum ... swung away from early treatment" after research conducted in the 1990s indicated that long-term treatment might increase the risk of developing drug resistance, "now it is swinging back" for several reasons, the Post reports. Most antiretroviral treatment regimens allow HIV-positive people to take one pill daily, newer drugs have fewer side effects and there are "hundreds of possible combinations of the nearly two dozen antiretrovirals on the market," according to the Post. In addition, results from the Strategies for Management of Antiretroviral Therapy, which indicated that suppressing HIV levels in the bloodstream might benefit the entire body and not just the immune system, "offered one more reason to consider early treatment," the Post reports (Brown, Washington Post, 1/7).

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