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Antiretroviral Therapy for Advanced HIV Disease in South Africa

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.
ClinicalTrials.gov Identifier: NCT00342355
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : April 16, 2013
Last Update Posted : May 21, 2013
Information provided by (Responsible Party):
Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

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

  Baseline Characteristics

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 Analyzed 
[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

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

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

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
e-mail: mpolis@niaid.nih.gov

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

Responsible Party: Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00342355     History of Changes
Other Study ID Numbers: 999904094
04-I-N094 ( Registry Identifier: NCT00342355 )
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: September 14, 2009
Results First Posted: April 16, 2013
Last Update Posted: May 21, 2013