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Antiretroviral Therapy for Advanced HIV Disease in South Africa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00342355
First Posted: June 21, 2006
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Results First Submitted: September 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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


  Outcome Measures
  Show All Outcome Measures

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