Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to determine whether 6 months of anti-HIV drugs given along with
      tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
    

Detailed description: 
      Tuberculosis (TB) is a common and serious complication of HIV infection in the developing
      world, especially in sub-Saharan Africa. Since the emergence of the HIV epidemic in Africa,
      the incidence rates of TB have risen dramatically, overwhelming national TB control programs
      across the continent. Over 50% of TB patients presenting to TB clinics in Africa are HIV
      infected. These patients often present in the early stages of HIV infection.

      Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB
      recommend antiretroviral (ARV) therapy in patients with CD4 cells less than 200 cells/mm3,
      but not for HIV infected TB patients who present with a high CD4 count. In Uganda, over half
      of HIV infected patients with active TB present to TB clinics with CD4 counts above 200
      cells/mm3, and there is evidence that coinfected patients with a high CD4 count should be
      treated with ARV therapy. First, mortality in HIV-associated TB is high, even when patients
      respond to effective anti-tuberculosis therapy. Second, excess mortality associated with TB
      is most evident when CD4 counts are above 200 cell/mm3. Third, in coinfected patients, TB
      results in prolonged immune activation, which may enhance viral replication and accelerate
      the decline of CD4 cells.

      This study will evaluate whether short-term ARV therapy of abacavir sulfate, lamivudine, and
      zidovudine given during treatment of active TB will slow progression of HIV disease in TB
      patients with CD4 counts of at least 350 cells/mm3. The study will also assess the possible
      risks (e.g., drug toxicities and resistance) and benefits (e.g., more rapid clearance of
      mycobacterium tuberculosis and reduced TB relapse) of punctuated ARV therapy.

      Participants in this study will be HIV infected TB patients with CD4 counts of at least 350
      cells/mm3. All participants will receive treatment for TB. Participants will be randomly
      assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop
      below 250 cells/mm3. The participants will be followed for 2 years; CD4 counts will be
      compared between groups.

      This study will also follow a group of HIV infected patients without active TB to quantify
      the extent to which CD4 cell decline is accelerated with active TB and to determine the
      extent to which a decline is neutralized in patients who receive punctuated ARV therapy.
    

Intervention name(s): Abacavir; Lamivudine; Zidovudine; Tuberculosis treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 300 mg tablet taken orally twice daily; 300 mg tablet taken orally daily; 300 mg tablet taken orally twice daily; Tuberculosis treatment
Intervention MeSH terms: Lamivudine; Zidovudine; Abacavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiretroviral Therapy; Africa