Status:
COMPLETED
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
Lead Sponsor:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infection
Tuberculosis
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB). Study hypothesis: Immediate antiretroviral therapy (ART), initia...
Detailed Description
Tuberculosis (TB) is the most important co-infection in the HIV epidemic; the bi-directional relationship between the two diseases is well established. HIV increases the risk for TB acquisition, react...
Eligibility Criteria
Inclusion
- HIV-infected.
- Confirmed or probable TB (more information on the criterion can be found in the protocol).
- Chest x-ray within 30 days prior to study entry.
- Receipt of 1-14 cumulative days of rifampin- or other rifamycin-based TB treatment that was initiated within 28 days prior to study entry.
- CD4 count less than 250 cells/mm\^3 within 30 days prior to study entry.
- Willing to use acceptable methods of contraception while on study drugs and for 6 weeks after stopping these drugs.
- Able to swallow oral medications.
- Parent of guardian willing to provide informed consent, if applicable.
- Karnofsky performance score =\>20 at time of study entry.
Exclusion
- ART for longer than 7 cumulative days prior to study entry or treatment for any period of time with one or more antiretrovirals. Participants who have taken ART during pregnancy or for occupational exposure are not excluded.
- Allergy or sensitivity to any of the study drugs or their formulations.
- History of multidrug-resistant TB.
- Receipt of any investigational therapy or chemotherapy within 30 days prior to study entry.
- Certain medications.
- Breastfeeding.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
809 Patients enrolled
Trial Details
Trial ID
NCT00108862
Start Date
August 1 2006
End Date
July 1 2010
Last Update
October 11 2018
Active Locations (26)
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1
University of Southern California (1201)
Los Angeles, California, United States, 90033-1079
2
University of California, San Diego, AVRC CRS (701)
San Diego, California, United States, 92103
3
University of California, San Francisco AIDS CRS (801)
San Francisco, California, United States, 94110
4
NY Univ. HIV/AIDS CRS (401)
New York, New York, United States, 10016