HIV Infections Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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