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Antiretroviral Therapy for Advanced HIV Disease in South Africa

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ClinicalTrials.gov Identifier: NCT00342355
Recruitment Status : Completed
First Posted : June 21, 2006
Results First Posted : April 16, 2013
Last Update Posted : May 21, 2013
Sponsor:
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

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

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 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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


  Serious Adverse Events


  Other Adverse Events

Time Frame 24.7 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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

Other Adverse Events
    AZT+ddI+EFV   AZT + ddI + r/LPV   d4T + 3TC + EFV   d4T + 3TC + r/LPV
Total, Other (not including serious) Adverse Events         
# participants affected / at risk   0/444 (0.00%)   0/440 (0.00%)   0/444 (0.00%)   0/443 (0.00%) 



  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
No text entered.


  More Information