Triomune Bioequivalence With Innovators

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborator: University of California, San Francisco
• Treatments: Lamivudine; Nevirapine; Stavudine; Stavudine, lamivudine, nevirapine drug combination

Criteria

Inclusion Criteria:

1. HIV-infected men and non-pregnant women;

2. On Triomune for at least 4 weeks;

3. 18 years or greater;

4. Residing within 15km of Kampala city center

Exclusion Criteria:

1. Unable to sign or understand informed consent

2. Concurrent medication known to interact with any of the components of Triomune

3. Patients with active TB, malabsorption, nausea, emesis, abdominal discomfort, chronic diarrhoea, documented active clinically relevant hepatitis;

4. Patients expected to change their drug regimen or dosage during the study

5. Those planning to move out of Kampala in the next two months;

6. Hemoglobin <7.0 mmol/l (men) or <6.5 mmol/l (women);

7. Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal;

8. Serum creatinine > 1.5 times the upper limit of normal