MedTrace Logo

Comparison of Nevirapine and Efavirenz for the Treatment of HIV-TB Co-infected Patients (ANRS 12146 CARINEMO)

NCT00495326 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2012-02-15

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of Nevirapine in HIV patients already treated against tuberculosis by Rifampicin is as efficient and as well tolerated as Efavirenz.

Conditions

Interventions

DRUG

Nevirapine based therapy

* Patients below 60 kg: 1 tablet twice a day of Triomune30®, including NVP 200 mg, 3TC 150 mg and D4T 30mg * Patients above 60kg: 1 tablet twice a day of Triomune40®, including NVP 200 mg, 3TC 150 mg and D4T 40 mg)

DRUG

Efavirenz based therapy

Efavirenz EFV 200 mg (3 tablets/d) Lamivudine 3TC 300mg (2 tablets of 150mg/d) D4T generic 30mg or 40mg (2 tablets/d)

DRUG

Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)

* Intensive phase: 2 months daily E(RMP)HZ. PTB smear positive patients at month 2 will receive 1 more month intensive phase. * Continuation phase: 4 months daily H(RMP). * Patients with meningitis will receive Streptomycin instead of E during intensive phase.

Sponsors & Collaborators

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Maryline Bonnet, MD · Epicentre

  • Nilesh Bhatt, MD · Ministry of Health, Instituto Nacional de Saude, Mozambique

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • Mozambique

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00495326 on ClinicalTrials.gov