Phase 4
N=20
Triomune Bioequivalence With Innovators
HIV/AIDS
Bottom Line
View on ClinicalTrials.gov: NCT01025830 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Area Under the Concentration-Time Curve(AUC) — 3.6; 3.4; 85.8; 79.2 hour*milligram/liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Triomune (Drug); Zerit/Epivir/Viramune (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Makerere University
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve(AUC) |
3.6; 3.4; 85.8; 79.2; 5.2; 6.4 | — |
| SECONDARY Maximum Plasma Concentration of Drug |
1.6; 1.3; 8.8; 8.4; 1.0; 1.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- HIV-infected men and non-pregnant women;
- On Triomune for at least 4 weeks;
- 18 years or greater;
- Residing within 15km of Kampala city center
Exclusion Criteria
- Unable to sign or understand informed consent
- Concurrent medication known to interact with any of the components of Triomune
- Patients with active TB, malabsorption, nausea, emesis, abdominal discomfort, chronic diarrhoea, documented active clinically relevant hepatitis;
- Patients expected to change their drug regimen or dosage during the study
- Those planning to move out of Kampala in the next two months;
- Hemoglobin 5 times the upper limit of normal;
- Serum creatinine > 1.5 times the upper limit of normal
Data sourced from ClinicalTrials.gov (NCT01025830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.