Researchers at several sites in the U.S. recruited 21 HIV positive subjects for this study which compared the effect of two different boosted protease inhibitor (PI) regimens:

• saquinavir (Fortovase) 400 mg with ritonavir (Norvir) 400 mg, both twice daily
• saquinavir 1,000 mg with ritonavir 100 mg, both twice daily

The combinations were taken with two or more other anti-HIV drugs.

The profile of subjects was as follows:

• 3 females, 18 males
• average age – about 40 years
• average CD4+ count ranged between 400 and 700 cells
• average viral load – fewer than 400 copies

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.

Results

Three subjects left the study for the following reasons:

• painfully swollen pancreas gland, or pancreatitis (2 males)
• very high levels of cholesterol and triglycerides (1 female)

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?

REFERENCE

O'Brien WA, Acosta E, Felizarta F, et al. Switch of saquinavir 400 mg/Ritonavir 400 mg to saquinavir 1,000 mg/Ritonavir 100 mg during BID four drug antiretroviral therapy. 3rd International Workshop on Clinical Pharmacology of HIV Therapy, Washington D.C., 11-13 April, 2002; abstract 2.1.

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