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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients

NCT00398996

HIV Infections Tuberculosis

COMPLETED PHASE3

REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment

NCT01380080

HIV Infection

COMPLETED PHASE4

Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis

NCT00108862

HIV Infection Tuberculosis

COMPLETED PHASE4

Tuberculosis Recurrence Upon Treatment With Highly Active Antiretroviral Therapy

NCT01539005

Tuberculosis

COMPLETED

Prevention of Early Mortality by Presumptive Tuberculosis (TB) Treatment

NCT01417988

HIV Infection Tuberculosis

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study intends to determine the optimal time to start ART by comparing three treatment strategies of ART initiation in HIV/TB co-infected patients. Four hundred fifty newly diagnosed HIV infected patients with active TB and CD4 cell count \< 200 cells/mm3 will be prospectively recruited to be assigned randomly in parallel into one of the three treatment groups (n=150 in each group) and HAART will be started at different time points as described below with extensive counseling and adherence support.

* Arm-A (Immediate Treatment Group): Receipt of antiretroviral therapy one week after starting anti-TB treatment.
* Arm-B (Deferred Treatment Group-1): Antiretroviral therapy will be initiated at the 4th week of starting anti-TB treatment (in the middle of the intensive phase TB treatment).
* Arm-C (Deferred Treatment Group-2): Antiretroviral therapy will be initiated at the 8th week of starting anti-TB treatment (after completion of the intensive phase of TB treatment).

Study Design: Interventional, prospective, randomized, open-label three-armed trial with no placebo, Active control, parallel assignment, safety and efficacy study.

Study population: Previously untreated HIV-infected adult patients with TB and CD4 cell counts \< 200/mm3 at the time of TB diagnosis.

Expected Total Enrollment = 450

Treatment: Patients will receive first-line preferred regimen for patients with TB and HIV coinfection (rifampicin containing short course TB treatment and efavirenz-containing HAART regimen. The intensive phase of anti-TB therapy consists of 2 months treatment with Rifampicin, Isoniazid, Pyrazinamide and Ethambutol followed by the continuation phase with Isoniazid and Rifampicin daily for 4 months under Directly Observed Therapy (DOTS). After the initiation of TB treatment, patients in Arm-A, Arm-B and Arm-C will start EFV-containing HAART regimen (efavirenz + Lamivudine (3TC) + Stavudine (d4T) after one week, in the middle(at 4th week) and at the end (8th week) of the intensive phase TB treatment respectively. Primar prophylaxis with cotrimoxazole will be offered to all patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acquired Immunodeficiency Syndrome Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm-A

Immediate Treatment Group

Group Type ACTIVE_COMPARATOR

Comparison of different treatment strategies

Intervention Type OTHER

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

Arm-B

Deferred Treatment Group-1

Group Type ACTIVE_COMPARATOR

Comparison of different treatment strategies

Intervention Type OTHER

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

Arm-C

Deferred Treatment Group-2

Group Type ACTIVE_COMPARATOR

Comparison of different treatment strategies

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comparison of different treatment strategies

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

Intervention Type OTHER

Comparison of different treatment strategies

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

Intervention Type OTHER

Comparison of different treatment strategies

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Treatment Treatment Treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed ART naive HIV infected patients and age \> 18 years old
* Newly diagnosed smear +ve PTB cases (abnormal CXR and at least one sputum sample +ve for AFB)
* Newly diagnosed smear -ve PTB cases (CXR consistent with active TB plus at least two sputum specimens negative for AFB and decision by the physician to treat for TB or smear negative for AFB but culture positive cases)
* Tissue biopsy or FNAC results consistent with the diagnosis of tuberculosis
* CD4 cell count \< 200/mm3 at the time of TB diagnosis
* Residence in Addis Ababa, Ethiopia
* Ability to give signed written/thumb sign informed consent

Exclusion Criteria

* Pregnancy and breast-feeding women
* Patients who received anti TB therapy with in the past two years
* Patients who have previous treatment experience with antiretroviral therapy
* Severely ill patients Karnofsky performance status score \< 40
* Baseline Hgb \< 8 gms/dL

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No