Study Finds Less Intensive Treatments May Not Maintain HIV S...( RNA/ml of blood were randomized to rece...),Health

RNA/ml of blood were randomized to receive either the same triple-drug therapy as before, a two-drug combination of AZT and 3TC, or monotherapy with IDV. Researchers led by Diane Havlir, M.D., and Douglas Richman, M.D., of the University of California San Diego AIDS Clinical Trials Unit, measured study participants' viral loads at regular intervals. The primary endpoint of the study was viral load rebound - defined as two consecutive viral load measurements of at least 200 copies/ml.

The investigators found that viral load rebound occurred in a total of 51 study participants: four in the triple-therapy group, 24 in the double-therapy group and 23 in the monotherapy group. The difference between the triple-therapy group and each of the other groups was statistically significant. However, among patients who had not taken AZT before entering the study, the difference between the triple- and double-therapies was not statistically significant.

High viral load at entry to the study and slower rates of viral clearance during the induction phase of the study were identified as risk factors for viral load rebound. The presence of AZT-resistance mutations in HIV RNA was strongly predictive of viral load rebound in individuals in the double-therapy group.

"Interestingly, the magnitude of the increase in CD4+ T-cell count during the triple-drug therapy phase of the study also correlated highly with subsequent viral load rebound. For each increase of 100 in the CD4+ T-cell count, there was a 30 percent increase in the risk of rebound." Dr. Havlir explains that an increase in the number of CD4+ T cells increases the number of target cells available for new HIV infection, which could occur when less intensive therapies are instituted.

The researchers conclude that maintaining HIV suppression with antiretroviral therapy leaves little margin for error. Poor adherence to even one component of a regimen may result in viral load rebound.

"Although the results
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Contact: John Bowersox
jbowersox@nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
28-Oct-1998

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