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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  
Number of 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Michael A Polis, MD, MPH
Organization: National Institute of Allergy and Infectious Diseases, Dvision of Clinical Research
phone: 301-496-8027

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00342355     History of Changes
Other Study ID Numbers: 999904094
04-I-N094 ( Registry Identifier: NCT00342355 )
Study First Received: June 19, 2006
Results First Received: September 14, 2009
Last Updated: April 29, 2013
Health Authority: United States: Federal Government