HIV Infections
Conditions
Keywords
HIV/AIDS
Brief summary
The purpose of this study is to evaluate the safety and efficacy of a novel nucleoside sparing regimen containing atazanavir, ritonavir and efavirenz, using two different doses of atazanavir.
Interventions
DRUGAtazanvir/ritonavir + efavirenz
Capsules (ATV and RTV) Tablets (EFV), Oral, ATV 300 mg + RTV 100 mg + EFV 600 mg, Once daily, 48 weeks.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent * HIV positive with plasma HIV RNA viral load of ≥ 1000 copies/mL and CD4 cell count of ≥ 50 cells/mm3 * Antiretroviral (ARV) naive prior to enrollment * Normal plasma triglycerides ≤ 200 mg/dL * Women of child-bearing age must use effective barrier contraception
Exclusion criteria
* Pregnancy or breast feeding * Evidence of resistance to antiretroviral drugs * History of elevated blood cholesterol or triglycerides * History of diabetes * Hypersensitivity to any component of the study drugs * Any cholesterol or triglyceride lowering medications in the past six months * Use of growth hormone, megestrol acetate, or anabolic steroids in the past six months * Imprisonment or involuntary incarceration for medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in fasting plasma triglycerides at Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of grade 2-4 elevation of fasting plasma triglycerides at Week (Wk) 8, 24 and 48 | — |
| The mean percent change from baseline in fasting plasma triglycerides at Wk 24 and 48 | — |
Countries
United States
Outcome results
None listed