June 29, 1998
Despite the wealth of data that has been gathered over the past few years, the efficacy of treating HIV soon after infection remains an open question, which this trial (known as ICC-004) seeks to answer.
This is an ongoing 192-week trial that has enrolled 198 patients with early HIV infection. Early infection was defined in the study as HIV levels greater than 1,000 copies/mL, CD4 cell counts of at least 500 cells/mm3, no previous treatment with an antiretroviral and no history of HIV-associated conditions.
Mean baseline viral load was a relatively low 8,069 copies per mL. At Week 16, 98% of patients (161 out of 164 who had reached the Week 16 point) had HIV suppressed to below detection (under 400 copies/mL) with the protease inhibitor indinavir, combined with AZT and 3TC (36 of the patients switched from ZDV to d4T due to side effects). Using a more sensitive test, researchers found 85 % of patients had under 50 copies/mL. The 98% undetectable figure has been maintained among the 55 patients who have reached Week 24. Even though the mean baseline CD4 cell count was in the normal range (602 cells), patients at Week 24 still saw a mean increase of nearly 150 cells. The drugs have been well-tolerated, and there have been very few drop-outs.
While these are early results, these patients will be followed for a full four years, with data being presented at future medical conferences. It is hoped that this data will help determine how early one should begin aggressive antiviral treatment.