Trials / Unknown
UnknownNCT00759070
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Juan A. Arnaiz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tenofovir + emtricitabine + efavirenz | Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) \+ Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily |
| DRUG | Tenofovir + emtricitabine + lopinavir/ritonavir | Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2013-07-01
- Completion
- 2013-07-01
- First posted
- 2008-09-25
- Last updated
- 2013-02-22
Locations
5 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT00759070. Inclusion in this directory is not an endorsement.