Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01025830
Other study ID # BETr
Secondary ID
Status Completed
Phase Phase 4
First received April 21, 2009
Last updated December 31, 2009
Start date February 2006
Est. completion date March 2008

Study information

Verified date December 2009
Source Makerere University
Contact n/a
Is FDA regulated No
Health authority Uganda: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of Lamivudine, Stavudine and Nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received Lamivudine (150 mg), Stavudine (40 mg), and Nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0-12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand-name within the 90% confidence interval of 0.8-1.25.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 2008
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Triomune
Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day
Zerit/Epivir/Viramune
Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.

Locations

Country Name City State
Uganda Makerere University Kampala

Sponsors (2)

Lead Sponsor Collaborator
Makerere University University of California, San Francisco

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

Byakika-Tusiime J, Chinn LW, Oyugi JH, Obua C, Bangsberg DR, Kroetz DL. Steady state bioequivalence of generic and innovator formulations of stavudine, lamivudine, and nevirapine in HIV-infected Ugandan adults. PLoS One. 2008;3(12):e3981. doi: 10.1371/jou — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Concentration-Time Curve(AUC) Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing No
Secondary Maximum Plasma Concentration of Drug Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing No
See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03215901 - Life Plans Intervention Study N/A
Completed NCT03289676 - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV Phase 1
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting NCT04064567 - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK N/A
Completed NCT04013295 - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya N/A
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT03984136 - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM N/A
Completed NCT02928900 - Patient Actor Training to Improve HIV Services for Adolescents in Kenya N/A
Recruiting NCT03268109 - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed NCT02797262 - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System N/A
Completed NCT02376582 - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS Phase 1
Completed NCT01957865 - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda N/A
Completed NCT01616940 - Minority AIDS Initiative Retention and Re-Engagement Project N/A
Terminated NCT01443923 - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV Phase 4
Completed NCT01910714 - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth N/A
Completed NCT01084421 - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos N/A
Completed NCT01596322 - International HIV Antiretroviral Adherence, Resistance and Survival N/A
Completed NCT03643705 - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention N/A
Completed NCT03923231 - Pharmacokinetics of Atazanavir in Special Populations