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Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis

NCT01315301 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2011-03-15

No results posted yet for this study

Summary

Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB co-infected patients who recently started treatment for Tuberculosis by comparing immediate versus deferred initiation of HAART.

The study will address the following questions;

* Is it possible to reduce mortality rate and increase survival by early initiation of HAART during TB treatment with out compromising for adverse drug reaction, toxicity and immune reconstitution syndrome?
* What is the risk/ benefit ratio between immediate versus deferred initiation of HAART during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?
* When is the most appropriate time to start HAART during TB treatment?

Conditions

Interventions

OTHER

Comparison of different treatment strategies

600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment.

OTHER

Comparison of different treatment strategies

600 mg efavirenz based HAART initiated four weeks after starting rifampicin based short course anti tuberculosis treatment

OTHER

Comparison of different treatment strategies

600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment.

Sponsors & Collaborators

Principal Investigators

  • Eleni Aklillu, PhD · Krolinska Institutet, Stockholm, Sweden

  • Wondwossen Amogne, MD · Addis Ababa University, Addis Ababa, Ethiopia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-01-31
Completion
2012-03-31

Countries

  • Ethiopia

Study Locations

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Entities

Diseases
Companies

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 NCT01315301 on ClinicalTrials.gov