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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851630
First Posted: February 26, 2009
Last Update Posted: May 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
Kibongoto National Tuberculosis Hospital, Tanzania
GlaxoSmithKline
Information provided by:
Duke University
Results First Submitted: March 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV
Tuberculosis
Intervention: Drug: Fixed dose combination zidovudine/lamivudine/abacavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment began in June 2004 and was completed in September 2005. Patients were enrolled at one of two hospitals in the Kilimanjaro Region of Tanzania.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Early Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
Delayed Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy

Participant Flow:   Overall Study
    Early   Delayed
STARTED   35   35 
COMPLETED   33   33 
NOT COMPLETED   2   2 
Death                2                1 
Clinical failure                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Early Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
Delayed Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
Total Total of all reporting groups

Baseline Measures
   Early   Delayed   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   35   70 
Age 
[Units: Participants]
     
<=18 years   1   0   1 
Between 18 and 65 years   34   35   69 
>=65 years   0   0   0 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 36.0 
 (32.4 to 43.6) 
 36.7 
 (32.4 to 44.3) 
 36.2 
 (32.4 to 43.6) 
Gender 
[Units: Participants]
     
Female   12   17   29 
Male   23   18   41 
Region of Enrollment 
[Units: Participants]
     
Tanzania   35   35   70 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Serious Adverse Events (SAEs)   [ Time Frame: 104 weeks ]

2.  Primary:   Tuberculosis-immune Reconstitution Inflammatory Syndrome Events   [ Time Frame: 104 weeks ]

3.  Secondary:   Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml   [ Time Frame: 104 Weeks ]

4.  Secondary:   HIV RNA Level < 50 Copies/ml   [ Time Frame: 104 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information