A randomized, open-label, comparative trial of BID and TID dosing of saquinavir enhanced oral formulation as part of a triple therapy for advanced AIDS patients.

Abstract

OBJECTIVE:

To compare the efficacy and safety of 1,400 mg BID and 1,200 mg TID of saquinavir soft gel given with zidovudine and lamivudine in antiretroviral-naïve, advanced AIDS patients.

METHOD:

A randomized, open-label study conducted at a university hospital.

RESULTS:

Forty cases were enrolled in the study, 20 cases in each group. The mean CD4 cell count was 29 cells/mm3. The mean log10 HIV-1 RNA was 5.27 copies/mL. Using an on-treatment analysis, the reduction in plasma log10HIV-1 RNA of BID and TID groups was not statistically significant at -2.44 vs -2.60 copies/mL (-0.16, 95% CI -0.63 to 0.30; p= 0.48). The mean increase in CD4 cell counts was not statistically significant at +144 and +159 cells/mm3 (11, 95% CI -75 to 97; p=0.79).

CONCLUSION:

The preliminary data suggests that in antiretroviral-naïve, advanced AIDS patients, 1,400 mg BID of saquinavir soft gel given with two nucleoside analogues might be as effective as the standard 1,200 mg TID.

• Authors: Ploenchan Chetchotisakd, Siriluck Anunnatsiri, Jaturaporn Wankun, Piroon Mootsikapun, Parichart Boonyaprawit
• Journal: Journal of the Medical Association of Thailand = Chotmaihet thangphaet (J Med Assoc Thai) Vol. 85 Issue 5 Pg. 590-6 (May 2002) ISSN: 0125-2208 [Print] Thailand
• PMID: 12188390 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• HIV Protease Inhibitors
• RNA, Viral
• Reverse Transcriptase Inhibitors
• Lamivudine
• Zidovudine
• Saquinavir

Topics

• Acquired Immunodeficiency Syndrome (drug therapy)
• Adult
• Antiretroviral Therapy, Highly Active
• Female
• HIV Protease Inhibitors (administration & dosage)
• HIV-1 (genetics)
• Humans
• Lamivudine (administration & dosage)
• Male
• RNA, Viral (analysis)
• Reverse Transcriptase Inhibitors (administration & dosage)
• Saquinavir (administration & dosage)
• Zidovudine (administration & dosage)