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Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment

NCT00332306 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2009-10-08

No results posted yet for this study

Summary

Protocol Summary

Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial

Phase: Phase III trial

Population: 180 HIV-1 positive patients with tuberculosis

Number of Sites: Four.

1. Tuberculosis Research Centre, Chennai
2. Government Medical College, Vellore
3. Government Hospital of Thoracic Medicine, Tambaram
4. Government Rajaji Hospital, Madurai

Study Duration: 26 months including 24 months of ART.

Study Objectives:

Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points.

Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).

Conditions

Interventions

DRUG

Didanosine, Lamivudine, Efavirenz

Didanosine 250mg patients \<60kg, 400mg patients \> 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months

DRUG

Didanosine, Lamivudine, Nevirapine

Didanosine 250 mg once daily for patients \< 60kg, 400 mg OD patients \> 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months

Sponsors & Collaborators

  • National AIDS Control Organisation

    collaborator OTHER

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Tuberculosis Research Centre, India

    lead OTHER_GOV

Principal Investigators

  • Soumya Swaminathan, MD · Tuberculosis Research Centre, India

  • PR Narayanan, PhD · Tuberculosis Research Centre, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-06-30
Completion
2011-12-31

Countries

  • India

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 NCT00332306 on ClinicalTrials.gov