CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Triomune +1 moredrug
Likely dose
Triomune 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01025830
NCT01025830Phase 4Completed
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Steady State Bioequivalence of Generic and Innovator Formulations of Stavudine, Lamivudine, and Nevirapine in HIV-infected Ugandan Adults

Makerere University·interventional·Posted Dec 4, 2009·Updated Jan 5, 2010

In Brief

A Phase 4 clinical trial evaluating Triomune and Zerit/Epivir/Viramune for HIV/AIDS. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV/AIDS
CountriesUganda
CollaboratorsUniversity of California, San Francisco

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2009
Enrollment StartFeb 1, 2006
Primary CompletionJun 1, 2006
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.6 years ago

Interventions

Triomunedrug

Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day

Zerit/Epivir/Viramunedrug

Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.