AEGiS-ATDN: Week On, Week Off Therapy

Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date.

Week On, Week Off Therapy

Information Bulletin #14 - March 2002

The results of a 10 person study led by Dr. Mark Dybul and NIAID Director Anthony S. Fauci were recently released. NIAID calls this approach Structured Interrupted Therapy (SIT). This report was written from a press release distributed by NIAID. Upon study entry, patients were receiving daily combinations of three or four anti-HIV drugs that had kept patients' HIV levels below 500 copies per milliliter (mL) of plasma for more than six months, and below 50 copies/mL at the time of enrollment. Everyone had at least 300 CD4 cells.

After enrollment in the NIAID study, patients received a four-drug regimen containing stavudine, lamivudine, indinavir and ritonavir, taken twice daily for seven days, followed by seven days off therapy. This on-off cycle was repeated 16 to 34 times - that is, for 32 to 68 weeks. During the study, participants had no significant increases in the amount of HIV in their bodies, as determined by tests that measured HIV in their plasma and lymph nodes, as well as within immune cells. In addition, CD4 counts were maintained at pre-study levels. No evidence suggested the development of resistance to HAART medications. Importantly, the investigators also noted significant decreases in serum cholesterol and triglyceride levels, which frequently are elevated in HIV-infected individuals receiving HAART, and which can contribute to heart disease and other problems. Mean serum cholesterol and triglyceride levels dropped 22 percent and 51 percent, respectively, after 24 weeks of intermittent therapy.

The initial results of this very small study are encouraging, but this strategy has not been shown to be safe or effective in a diverse group of HIV-positive individuals with varying treatment histories and conditions (such as hepatitis co-infection). It is possible that using this approach with NNRTI type drugs, such as Viramune, Sustiva, or Rescriptor, could be disastrous. Many questions remain unanswered.

The Web Site of the NIAID Laboratory of Immunoregulation is http://www.niaid.nih.gov/dir/labs/lir.htm. For information about a randomized, controlled trial at NIH of short cycle intermittent HAART versus continuous HAART for the treatment of chronic HIV infection, please call 1-800-772-5464, ext. 58003. For information about AIDS clinical trials nationwide, please call the AIDS Clinical Trials Information Service at 1-800-TRIALS-A or visit a href="http://www.actis.org">http://www.actis.org.
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