Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings

March 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Implementing Anti-Retroviral Therapy in Resource-Constrained Settings: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberculosis and HIV

Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in developing countries. The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB. Participants will be recruited from resource-poor communities in Durban, South Africa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TB is the most common serious infectious complication associated with HIV in sub-Saharan Africa and is also the most common cause of death among HIV infected patients in developing countries. Furthermore, TB in an HIV infected person accelerates the progression of HIV disease and hastens death. This study will evaluate a combined TB and antiretroviral treatment (ART) strategy utilizing DOT in HIV infected people coinfected with TB. This study will compare two treatment strategies: TB and HIV medications given concurrently (integrated arm) and TB treatment completed first, followed by HIV treatment (sequential arm).

This study has two parts. The entire study will last 24 months after participants have been randomly assigned to one of two arms. Arm 1 (integrated arm) participants will receive didanosine (ddI), efavirenz (EFV), and lamivudine (3TC) once daily concurrent with standard TB therapy. ART and TB medications will be provided through DOT on weekdays; participants will take their medications without DOT on weekends. Arm 1 participants will also attend four 15- to 20-minute sessions of an adherence study program at study start, Week 2, Month 2, and 1 to 3 weeks prior to the end of TB therapy.

Arm 2 (sequential arm) participants will first receive DOT-provided TB treatment alone. After completion of TB treatment, participants will receive ddI, EFV, and 3TC once daily without DOT.

Study visits in the first part of the study will occur at screening, study start, Weeks 1, 2, and 3, and every month until the end of the first part of the study at Month 12. Study visits will include blood collection, medical and medication history assessment, a physical exam, and pill counts. Patients will be asked to complete an adherence questionnaire at every study visit and a sexual behavior survey and quality of life questionnaire at study start and Month 6.

Study Type

Interventional

Enrollment (Anticipated)

592

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Durban
      • Congella, Durban, South Africa
        • King Edward VIII Hospital
      • Congella, Durban, South Africa
        • Prince Cyril Zulu CDC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for First Part of Study:

  • HIV infected
  • TB infected
  • Currently receiving standard anti-TB therapy (isoniazid, rifampicin, ethambutol, and pyrazinamide)
  • Currently participating in the Prince Cyril Zulu CDC Directly Observed Therapy (DOT) program and receiving treatment daily either there or in the community with a supervised community nurse or trained health worker
  • Intending to stay in the area for the duration of the study
  • Willing to participate in all follow-up visits
  • Willing to use acceptable forms of contraception
  • Female participants must be willing to have regular pregnancy tests during ART

Exclusion Criteria for First Part of Study:

  • Have had 28 days or more of cumulative ART prior to study entry. Participants who have taken mother-to-child transmission (MTCT) and postexposure prophylaxis (PEP) prevention treatments are not excluded.
  • Less than 10 days or greater than 28 days since starting current TB treatment
  • Body temperature greater than 38.5 C (101.3 F)
  • Rash, nausea, or vomiting of Grade 3 or higher
  • Hospitalized or referred for hospitalization for care and treatment of opportunistic infections, TB, or other causes at screening or enrollment
  • CD4 count less than 50 cells/microL within 28 days of study entry
  • TB meningitis or TB that has spread to the blood and organs other than the lungs
  • History of prior TB treatment or previous active TB episode unresponsive to a standard anti-TB regimen
  • History of or current AIDS-defining condition as defined by the World Health Organization (WHO)
  • History of or current pancreatitis
  • Peripheral neuropathy of Grade 2 or higher
  • Currently taking certain medications
  • Suspected multidrug resistant (MDR) TB
  • Any condition that, in the opinion of the investigator, may interfere with the study
  • Participation in any other study that may interfere with this study
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Diagnosis of an AIDS-defining illness
18-month mortality

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Salim S. Abdool Karim, MBChB, PhD, University of KwaZulu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Study Registration Dates

First Submitted

September 20, 2004

First Submitted That Met QC Criteria

September 20, 2004

First Posted (Estimate)

September 21, 2004

Study Record Updates

Last Update Posted (Estimate)

March 29, 2010

Last Update Submitted That Met QC Criteria

March 26, 2010

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPRISA START
  • START
  • CIPRA
  • CAPRISA 001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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