drugset / Trial / NCT00043953
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
RandomizedParallel-groupOpen-labelTreatment
Summary
The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
Timeline
- Start
- 2002-08
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 150 mg | — |
| Subject | Saquinavir | Small molecule | 400 mg | — |
| Subject | Saquinavir | Small molecule | 600 mg | — |
| Subject | Saquinavir | Small molecule | 800 mg | — |
| Subject | Zidovudine | Small molecule | 300 mg | — |
| Background | Lopinavir | Other / unclassified | 400 mg | — |
| Background | Ritonavir | Other / unclassified | 100 mg | — |