May 9, 2002
The combinations were taken with two or more other anti-HIV drugs.
The profile of subjects was as follows:
Before entering the study, all subjects were taking a combination of saquinavir and ritonavir (saq/rit) at a dose of 400/400 mg twice daily in combination with two or more anti-HIV drugs. Subjects were randomly assigned to receive one of the two above-mentioned PI dose combinations and were monitored for six months.
One subject, who was taking the 400/400-mg regimen had his viral load rise above the 1,000 copy mark during the study.
By the sixth month of the study, more subjects (9) on the 1,000/100 regimen had suppressed their viral load compared to subjects on the 400/400 regimen (6).
Over time, there were trends to lower triglyceride and cholesterol levels in subjects given 1,000/100. CD4+ counts were also higher in that group. As well, the 1,000/100 combination was better tolerated than the combination that included a higher dose of ritonavir. More details about tolerating saquinavir appear in our next CATIE News story: "Invirase vs. Fortovase -- Unexpected Results?"