Triomune Bioequivalence With Innovators

M

Makerere University

Status and phase

Completed
Phase 4

Conditions

HIV/AIDS

Treatments

Drug: Zerit/Epivir/Viramune
Drug: Triomune

Study type

Interventional

Funder types

Other

Identifiers

NCT01025830
BETr

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 <7.0 mmol/l (men) or <6.5 mmol/l (women);
  • Alanine aminotransferase or aspartate aminotransferase >5 times the upper limit of normal;
  • Serum creatinine > 1.5 times the upper limit of normal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Generic
Experimental group
Description:
generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune)
Treatment:
Drug: Triomune
Brand
Active Comparator group
Description:
3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)
Treatment:
Drug: Zerit/Epivir/Viramune

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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