At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Antiretroviral-naïve: ≤14 days of prior NRTI therapy; no prior PI or NNRTI
- ✓Plasma HIV-1 RNA ≥1,000 copies/mL at screening
- ✓Able to provide written informed consent
- ✕Active or acute CDC Category C event (except cutaneous Kaposi's sarcoma); if prior event, must be treated ≥30 days before screening
- ✕Enrolled in other investigational drug protocols that may impact HIV-1 RNA suppression
- ✕Pregnant or breastfeeding
- ✕Clinically relevant pancreatitis or hepatitis at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects
In Brief
A Phase 4 clinical trial evaluating emtricitabine/tenofovir and abacavir/lamivudine for HIV Infection. Completed, enrolled 688 participants across 74 sites in 2 countries.
Detailed Summary
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks
Study Details
Timeline
Interventions
The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.