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Triomune Bioequivalence With Innovators

NCT01025830 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-05

Study results available
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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.

Conditions

Interventions

DRUG

Triomune

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

DRUG

Zerit/Epivir/Viramune

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

Sponsors & Collaborators

Principal Investigators

  • Jayne Tusiime, B Pharm, MSc · Makerere University

  • David R Bangsberg, MD,MPH · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2006-06-30
Completion
2008-03-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01025830 on ClinicalTrials.gov