At a glance
ClinicalIndex Comparison Record- ✓HIV infection confirmed
- ✓Antiretroviral naive or minimal prior exposure (≤56 days of PMTCT drugs or <7 days total ART)
- ✓Viral load ≥5,000 copies/ml
- ✓Able to swallow study medications
- ✕Allergic to emtricitabine, efavirenz, didanosine, or their formulations
- ✕Kidney disease
- ✕Hepatitis B or C positive
- ✕Acute opportunistic or bacterial infection requiring treatment at entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study to Evaluate the Safety, Tolerance, Antiviral Activity, and Pharmacokinetics of Emtricitabine in Combination With Efavirenz and Didanosine in a Once-Daily Regimen in HIV Infected, Antiretroviral Therapy Naive or Very Limited Antiretroviral Exposed Pediatric Subjects
In Brief
A Phase 2 clinical trial evaluating Didanosine (ddI), Efavirenz (EFV), and 1 other intervention for HIV Infections. Completed, enrolled 43 participants across 18 sites in 2 countries.
Detailed Summary
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
Study Details
Timeline
Interventions
Antiretroviral Didanosine (ddI) : 240 mg/m\^2 up to a maximum of 400 mg once daily
Antiretroviral For Age Group 1 Efavirenz (EFV): dose adjusted for body size and for Age Groups 2 and 3 Efavirenz (EFV): up to a maximum of 600 mg once daily as a capsule ot 720 mg as an oral solution
Antiretroviral Emtricitabine (FTC): 6 mg/Kg up to a maximum of 200 mg once daily