At a glance
ClinicalIndex Comparison Record- ✓Treatment-naive HIV-1 infection with <10 days of prior antiretroviral therapy
- ✓HIV-1 RNA ≥5,000 c/mL at screening
- ✓CD4 count ≥50 cells/mm³
- ✓Age ≥18 years
- ✕Primary HIV infection
- ✕Newly diagnosed HIV-related opportunistic infection or acute medical condition requiring therapy at enrollment
- ✕Active alcohol or substance use sufficient to impair compliance or increase risk of pancreatitis/hepatitis
- ✕Prior ARV therapy >10 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing the Efficacy of a Treatment Maintenance Phase With Unboosted vs. Boosted Reyataz After an Induction Phase With Reyataz and Ritonavir in Treatment Naive HIV Patients (the INDUMA Study)
In Brief
A Phase 4 clinical trial evaluating Atazanavir + 2 NRTIs and Atazanavir + Ritonavir + 2 NRTIs for HIV Infections. Completed, enrolled 252 participants across 27 sites in 10 countries.
Detailed Summary
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remaining on ATV/RTV, whilst continuing their previous NRTI backbone.
Study Details
Timeline
Interventions
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)