Antiretroviral Therapy for Advanced HIV Disease in South Africa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00342355
First received: June 19, 2006
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: September 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Interventions: Drug: Zidovudine
Drug: Stavudine
Drug: Didanosine
Drug: Lamivudine
Drug: Efavirenz
Drug: Lopinavir/Ritonavir

  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
No text entered.

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
AZT+ddI+EFV Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV Stavudine + Lamivudine + Efavirenz
d4T + 3TC + r/LPV Stavudine + Lamivudine + lopinavir/ritonavir

Participant Flow:   Overall Study
    AZT+ddI+EFV     AZT + ddI + r/LPV     d4T + 3TC + EFV     d4T + 3TC + r/LPV  
STARTED     444     440     444     443  
COMPLETED     444     440     444     443  
NOT COMPLETED     0     0     0     0  



  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
AZT+ddI+EFV Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV Stavudine + Lamivudine + efavirenz
d4T + 3TC + r/LPV Stavudine + Lamivudine + lopinavir/ritonavir
Total Total of all reporting groups

Baseline Measures
    AZT+ddI+EFV     AZT + ddI + r/LPV     d4T + 3TC + EFV     d4T + 3TC + r/LPV     Total  
Number of Participants  
[units: participants]
  444     440     444     443     1771  
Age  
[units: years]
Mean ± Standard Deviation
  35.3  ± 5.4     35.3  ± 5.4     35.5  ± 5.5     35.6  ± 5.5     35.4  ± 5.4  
Gender  
[units: participants]
         
Female     146     135     144     142     567  
Male     298     305     300     301     1204  
Region of Enrollment  
[units: participants]
         
South Africa     444     440     444     443     1771  



  Outcome Measures
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1.  Primary:   Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.   [ Time Frame: January 2004 until March 31 2008 ]

2.  Secondary:   Serious Adverse Events   [ Time Frame: January 2004 until March 31, 2008 ]


  Serious Adverse Events
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Time Frame 24.7 months
Additional Description No text entered.

Reporting Groups
  Description
AZT+ddI+EFV Zidovudine + Didanosine+Efavirenz
AZT + ddI + r/LPV Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
d4T + 3TC + EFV Stavudine + Lamivudine + efavirenz
d4T + 3TC + r/LPV Stavudine + Lamivudine + lopinavir/ritonavir

Serious Adverse Events
    AZT+ddI+EFV     AZT + ddI + r/LPV     d4T + 3TC + EFV     d4T + 3TC + r/LPV  
Total, serious adverse events          
# participants affected / at risk     96/444 (21.62%)     85/440 (19.32%)     72/444 (16.22%)     71/443 (16.03%)  
Blood and lymphatic system disorders          
Blood and lymphatic system disorders        
# participants affected / at risk     12/444 (2.70%)     9/440 (2.05%)     5/444 (1.13%)     2/443 (0.45%)  
# events     12     9     5     2  
Gastrointestinal disorders          
Gastrointestinal        
# participants affected / at risk     21/444 (4.73%)     15/440 (3.41%)     10/444 (2.25%)     15/443 (3.39%)  
# events     21     15     10     15  
General disorders          
General Disorders        
# participants affected / at risk     7/444 (1.58%)     6/440 (1.36%)     7/444 (1.58%)     3/443 (0.68%)  
# events     7     6     7     3  
Hepatobiliary disorders          
Hepatobilary Disorders        
# participants affected / at risk     3/444 (0.68%)     6/440 (1.36%)     2/444 (0.45%)     3/443 (0.68%)  
# events     3     6     2     3  
Infections and infestations          
Infections and Infestattions † 1        
# participants affected / at risk     15/444 (3.38%)     15/440 (3.41%)     12/444 (2.70%)     12/443 (2.71%)  
# events     15     15     12     12  
Injury, poisoning and procedural complications          
Injury,poisoning, and procedure complications † 1        
# participants affected / at risk     8/444 (1.80%)     4/440 (0.91%)     4/444 (0.90%)     5/443 (1.13%)  
# events     8     4     4     5  
Metabolism and nutrition disorders          
Metabolism and Nutrition Disorders        
# participants affected / at risk     15/444 (3.38%)     8/440 (1.82%)     16/444 (3.60%)     15/443 (3.39%)  
# events     15     8     16     15  
Nervous system disorders          
Nervous System disorders † 1        
# participants affected / at risk     4/444 (0.90%)     5/440 (1.14%)     6/444 (1.35%)     6/443 (1.35%)  
# events     4     5     6     6  
Psychiatric disorders          
Psychiatric disorders † 1        
# participants affected / at risk     7/444 (1.58%)     8/440 (1.82%)     7/444 (1.58%)     3/443 (0.68%)  
# events     7     8     7     3  
Renal and urinary disorders          
Renal and Urinary Disorders † 1        
# participants affected / at risk     1/444 (0.23%)     4/440 (0.91%)     1/444 (0.23%)     4/443 (0.90%)  
# events     1     4     1     4  
Vascular disorders          
Vascular disorders † 1        
# participants affected / at risk     3/444 (0.68%)     5/440 (1.14%)     2/444 (0.45%)     3/443 (0.68%)  
# events     3     5     2     3  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events


  Limitations and Caveats
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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
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  More Information