Triomune Bioequivalence With Innovators

NCT01025830 | Completed Phase 4 Results

• 1 other identifier: BETr
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Keywords

HIV;Bioequivalence;Triomune

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration-Time Curve(AUC)

  Mean Area Under the Plasma Concentration-Time Curve for each drug, log transformed

  Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Secondary Outcomes (1)

• Maximum Plasma Concentration of Drug

  Assessed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 10 and 12 hr post-dosing

Study Arms (2)

Generic

EXPERIMENTAL

generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune)

Drug: Triomune

Brand

ACTIVE COMPARATOR

3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)

Drug: Zerit/Epivir/Viramune

Interventions

Triomune DRUG

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

Also known as: Stavudine, Lamivudine, Nevirapine

Generic

Zerit/Epivir/Viramune DRUG

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

Also known as: Stavudine, Lamivudine, Nevirapine

Brand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-infected men and non-pregnant women;
• On Triomune for at least 4 weeks;
• years or greater;
• Residing within 15km of Kampala city center

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Related 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/journal.pone.0003981. Epub 2008 Dec 19.

  PMID: 19096711 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

stavudine, lamivudine, nevirapine drug combination; Stavudine; Lamivudine; Nevirapine

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines

Limitations and Caveats

Stavudine (40mg) was used whereas currently it is Stavudine(30mg) that is recommended for usage. So our results may not be applicable to patients on Stavudine 30mg.

Results Point of Contact

• Title: Jayne Byakika Tusiime
• Organization: University of California Berkeley

tusiimej@berkeley.edu

1 510 219 7567

Study Officials

• Jayne Tusiime, B Pharm, MSc

  Makerere University

  PRINCIPAL INVESTIGATOR

• David R Bangsberg, MD,MPH

  Harvard University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: December 4, 2009
• Study Start: February 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: March 1, 2008
• Last Updated: January 5, 2010
• Results First Posted: December 4, 2009

Record last verified: 2009-12

Locations

UG (1)