Clinical Trial: Tuberculosis and Human Immunodeficiency Virus (HIV) Immune Reconstitution Syndrome Trial (THIRST)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Pilot Study Of Open-Label Fixed Dose Combination Zidovudine/Lamivudine/Abacavir In HIV-Infected Persons With Tuberculosis In Moshi, Tanzania; Tuberculosis And HIV Immune Recons

Brief Summary: The purpose of this study is twofold: (1) to assess the feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV infected subjects with tuberculosis in a resource-limited setting, and (2) to assess the impact of delayed versus early initiation strategies for fixed dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-associated immune reconstitution inflammatory syndromes.

Detailed Summary:
Sponsor: Duke University

Current Primary Outcome:

  • Number of Serious Adverse Events (SAEs) [ Time Frame: 104 weeks ]
    Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting as assessed by the number of serious adverse events. Serious adverse events included any untoward medical occurrence that resulted in death, was considered life-threatening, required inpatient hospitalization or prolongation of existing hospitalization beyond what was required in the study, or resulted in persistent or resulted in significant disability/incapacity.
  • Tuberculosis-immune Reconstitution Inflammatory Syndrome Events [ Time Frame: 104 weeks ]
    Tuberculosis-immune reconstitution inflammatory syndrome was defined by the protocol as: a) new persistent fevers (temperature >101.5 degrees Fahrenheit) developing after the initiation of antiretroviral therapy, and not believed to be associated with antiretroviral therapy and without an identifiable source, b) marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates or pleural effusions on radiologic examination, or c) worsening or emergence of lymphadenopathy on serial examinations or worsening of other tuberculous lesions.


Original Primary Outcome:

  • Feasibility and safety of fixed dose combination zidovudine/lamivudine/abacavir in HIV-infected subjects with tuberculosis in a resource-limited setting. [ Time Frame: 104 weeks ]
  • To assess the impact of delayed versus early initiation strategy for fixed-dose combination zidovudine/lamivudine/abacavir on the rate of tuberculosis-immune reconstitution inflammatory syndromes [ Time Frame: 104 weeks ]


Current Secondary Outcome:

  • Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml [ Time Frame: 104 Weeks ]
    The number of subjects with plasma HIV RNA level <400 copies/ml.
  • HIV RNA Level < 50 Copies/ml [ Time Frame: 104 Weeks ]
    The number of subjects with plasma HIV RNA level <50 copies/ml.


Original Secondary Outcome:

Information By: Duke University

Dates:
Date Received: February 25, 2009
Date Started: June 2004
Date Completion:
Last Updated: May 2, 2010
Last Verified: May 2010