A5221 - A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for HIV-Infected Persons Treated for Tuberculosis (TB) with CD4 <200 Cells/mm³

Eligible candidates:

• Must be HIV infected individuals at least 13 years old who have never taken anti-HIV drugs.
• have CD4 count of CD4 <200 Cells/mm³
• Have recently started TB treatment with rifampin (RIF) or other similar drug.
• Do not have known resistance to 2 or more anti-TB drugs.

Study Objective:
A5221 is a study to see whether people infected with HIV who are being treated for tuberculosis (TB) should start taking anti-HIV drugs earlier or later compared to when they start their anti-TB drugs. The study will compare the number of people surviving without getting a new AIDS-defining illness at the end of the study between people who start anti-HIV drugs as soon as they enter the study and people who don't start their anti-HIV drugs until later.

Study Scheme:
800 subjects will participate in this study, in the following treatment groups:

• Group A: Early anti-HIV treatment (within about 2 weeks after start of TB treatment)
• Group B: Delayed anti-HIV treatment (8-12 weeks after start of TB treatment)

Participants will be randomly assigned to a group at entry. The study is 48 weeks long.

Study Drugs:

• Efavirenz (EFV, Sustiva, or Stocrin) once a day (at bedtime)
• Emtricitabine (FTC, or Emtriva) once a day
• Tenofovir (TDF, or Viread) once a day

Study Status: Open for enrollment

Study Staff:

• Judith Aberg, MD
• Luis Vargas

Study Sponsors:

• AIDS Clinical Trials Group (NIH)

Study Volunteers Receive:

• Cost-free lab work
• Transportation reimbursement