Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
Kibongoto National Tuberculosis Hospital, Tanzania
GlaxoSmithKline
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00851630
First received: February 25, 2009
Last updated: May 2, 2010
Last verified: May 2010
Results First Received: March 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Tuberculosis
Intervention: Drug: Fixed dose combination zidovudine/lamivudine/abacavir

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title HIV RNA Level < 50 Copies/ml
Measure Description The number of subjects with plasma HIV RNA level <50 copies/ml.
Time Frame 104 Weeks  
Safety Issue No  

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.
Intent to Treat, missing = failure.

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

Measured Values
   Early   Delayed 
Participants Analyzed 
[Units: Participants]
 35   35 
HIV RNA Level < 50 Copies/ml 
[Units: Participants]
 23   26 

No statistical analysis provided for HIV RNA Level < 50 Copies/ml




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nathan Thielman
Organization: Duke University Medical Center
phone: 919-6687174
e-mail: n.thielman@duke.edu


Publications of Results:

Responsible Party: Nathan Thielman, MD, MPH, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00851630     History of Changes
Other Study ID Numbers: Pro00013131
Study First Received: February 25, 2009
Results First Received: March 15, 2009
Last Updated: May 2, 2010
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research
Tanzania: Food & Drug Administration