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

Antiretroviral Therapy for Advanced HIV Disease in South Africa

This study has been completed.
Information provided by (Responsible Party):
Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID) Identifier:
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

  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.
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Reporting Groups
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
Overall Participants 
[units: participants]
 444   440   444   443   1771 
[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) 
[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

  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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