Trials / Completed
CompletedNCT00043953
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lopinavir/ritonavir | |
| DRUG | Saquinavir mesylate | |
| DRUG | Lamivudine/zidovudine |
Timeline
- Start date
- 2002-08-01
- First posted
- 2002-08-19
- Last updated
- 2007-09-27
Locations
11 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00043953. Inclusion in this directory is not an endorsement.