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

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ClinicalTrials.gov Identifier: NCT00851630
Recruitment Status : Completed
First Posted : February 26, 2009
Results First Posted : January 8, 2010
Last Update Posted : May 4, 2010
Sponsor:
Collaborators:
Kilimanjaro Christian Medical Centre, Tanzania
Kibongoto National Tuberculosis Hospital, Tanzania
GlaxoSmithKline
Information provided by:
Duke University

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
Enrollment 70
Recruitment Details 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  
Arm/Group Title Early Delayed
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 35 35
Completed 33 33
Not Completed 2 2
Reason Not Completed
Death             2             1
Clinical failure             0             1
Arm/Group Title Early Delayed Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
<=18 years
1
   2.9%
0
   0.0%
1.0
Between 18 and 65 years
34
  97.1%
35
 100.0%
69.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Age Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
36.0
(32.4 to 43.6)
36.7
(32.4 to 44.3)
36.2
(32.4 to 43.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
12
  34.3%
17
  48.6%
29.0
Male
23
  65.7%
18
  51.4%
41.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Tanzania Number Analyzed 35 participants 35 participants 70 participants
35 35 70
1.Primary Outcome
Title Number of Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 104 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title Early Delayed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Events
12 7
2.Primary Outcome
Title Tuberculosis-immune Reconstitution Inflammatory Syndrome Events
Hide Description 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.
Time Frame 104 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title Early Delayed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Events
0 0
3.Secondary Outcome
Title Plasma HIV Ribonucleic Acid (RNA) Level < 400 Copies/ml
Hide Description The number of subjects with plasma HIV RNA level <400 copies/ml.
Time Frame 104 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat Analysis, missing = failure.
Arm/Group Title Early Delayed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Participants
26 31
4.Secondary Outcome
Title HIV RNA Level < 50 Copies/ml
Hide Description The number of subjects with plasma HIV RNA level <50 copies/ml.
Time Frame 104 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat, missing = failure.
Arm/Group Title Early Delayed
Hide Arm/Group Description:
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
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
Overall Number of Participants Analyzed 35 35
Measure Type: Number
Unit of Measure: Participants
23 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Delayed
Hide Arm/Group Description 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 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
All-Cause Mortality
Early Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Early Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/35 (34.29%)      7/35 (20.00%)    
Blood and lymphatic system disorders     
Anemia   2/35 (5.71%)  2 0/35 (0.00%)  0
Gastrointestinal disorders     
Acute intestinal obstruction  1/35 (2.86%)  1 0/35 (0.00%)  0
Esophageal variceal bleeding  0/35 (0.00%)  0 1/35 (2.86%)  1
Immune system disorders     
Allergic reaction to suphalene-pyrimethamine  0/35 (0.00%)  0 1/35 (2.86%)  1
Suspected abacavir hypersensitivity reaction  3/35 (8.57%)  3 1/35 (2.86%)  1
Infections and infestations     
Amebiasis  1/35 (2.86%)  1 0/35 (0.00%)  0
Cryptococcal meningitis  1/35 (2.86%)  1 0/35 (0.00%)  0
Malaria  2/35 (5.71%)  2 1/35 (2.86%)  1
Mycobacteremia with M. sherrisii  0/35 (0.00%)  0 1/35 (2.86%)  1
Syphilis  1/35 (2.86%)  1 0/35 (0.00%)  0
Nervous system disorders     
Head trauma, grand mal seizure  0/35 (0.00%)  0 1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders     
Tension pneumothorax  1/35 (2.86%)  1 0/35 (0.00%)  0
Skin and subcutaneous tissue disorders     
Disseminated kaposi's sarcoma  0/35 (0.00%)  0 1/35 (2.86%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Early Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
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
Responsible Party: Nathan Thielman, MD, MPH, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00851630     History of Changes
Other Study ID Numbers: Pro00013131
First Submitted: February 25, 2009
First Posted: February 26, 2009
Results First Submitted: March 15, 2009
Results First Posted: January 8, 2010
Last Update Posted: May 4, 2010