Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00091936|
Recruitment Status : Completed
First Posted : September 21, 2004
Last Update Posted : March 29, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Tuberculosis||Drug: Didanosine Drug: Efavirenz Drug: Lamivudine Drug: Standard TB treatment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||592 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2009|
- Diagnosis of an AIDS-defining illness
- 18-month mortality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091936
|King Edward VIII Hospital|
|Congella, Durban, South Africa|
|Prince Cyril Zulu CDC|
|Congella, Durban, South Africa|
|Study Chair:||Salim S. Abdool Karim, MBChB, PhD||University of KwaZulu|