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Trial record 4 of 6 for:    9287227 [PUBMED-IDS]

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
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
Enrollment 1771
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Hide Arm/Group Description Zidovudine + Didanosine+Efavirenz Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV] Stavudine + Lamivudine + Efavirenz Stavudine + Lamivudine + lopinavir/ritonavir
Period Title: Overall Study
Started 444 440 444 443
Completed 444 440 444 443
Not Completed 0 0 0 0
Arm/Group Title AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV Total
Hide Arm/Group Description Zidovudine + Didanosine+Efavirenz Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV] Stavudine + Lamivudine + efavirenz Stavudine + Lamivudine + lopinavir/ritonavir Total of all reporting groups
Overall Number of Baseline Participants 444 440 444 443 1771
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 444 participants 440 participants 444 participants 443 participants 1771 participants
35.3  (5.4) 35.3  (5.4) 35.5  (5.5) 35.6  (5.5) 35.4  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 444 participants 440 participants 444 participants 443 participants 1771 participants
Female
146
  32.9%
135
  30.7%
144
  32.4%
142
  32.1%
567.0
Male
298
  67.1%
305
  69.3%
300
  67.6%
301
  67.9%
1204.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
South Africa Number Analyzed 444 participants 440 participants 444 participants 443 participants 1771 participants
444 440 444 443 1771
1.Primary Outcome
Title Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.
Hide Description Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.
Time Frame January 2004 until March 31 2008
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Hide Arm/Group Description:
Zidovudine + Didanosine+Efavirenz
Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
Stavudine + Lamivudine + efavirenz
Stavudine + Lamivudine + lopinavir/ritonavir
Overall Number of Participants Analyzed 444 440 444 443
Measure Type: Number
Unit of Measure: participants
93 77 70 80
2.Secondary Outcome
Title Serious Adverse Events
Hide Description Safety outcomes in four different randomly assigned regimens
Time Frame January 2004 until March 31, 2008
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Hide Arm/Group Description:
Zidovudine + Didanosine+Efavirenz
Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
Stavudine + Lamivudine + efavirenz
Stavudine + Lamivudine + lopinavir/ritonavir
Overall Number of Participants Analyzed 444 440 444 443
Measure Type: Number
Unit of Measure: participant
73 69 64 60
Time Frame 24.7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Hide Arm/Group Description Zidovudine + Didanosine+Efavirenz Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV] Stavudine + Lamivudine + efavirenz Stavudine + Lamivudine + lopinavir/ritonavir
All-Cause Mortality
AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/444 (21.62%)      85/440 (19.32%)      72/444 (16.22%)      71/443 (16.03%)    
Blood and lymphatic system disorders         
Blood and lymphatic system disorders   12/444 (2.70%)  12 9/440 (2.05%)  9 5/444 (1.13%)  5 2/443 (0.45%)  2
Gastrointestinal disorders         
Gastrointestinal   21/444 (4.73%)  21 15/440 (3.41%)  15 10/444 (2.25%)  10 15/443 (3.39%)  15
General disorders         
General Disorders   7/444 (1.58%)  7 6/440 (1.36%)  6 7/444 (1.58%)  7 3/443 (0.68%)  3
Hepatobiliary disorders         
Hepatobilary Disorders   3/444 (0.68%)  3 6/440 (1.36%)  6 2/444 (0.45%)  2 3/443 (0.68%)  3
Infections and infestations         
Infections and Infestattions  1  15/444 (3.38%)  15 15/440 (3.41%)  15 12/444 (2.70%)  12 12/443 (2.71%)  12
Injury, poisoning and procedural complications         
Injury,poisoning, and procedure complications  1  8/444 (1.80%)  8 4/440 (0.91%)  4 4/444 (0.90%)  4 5/443 (1.13%)  5
Metabolism and nutrition disorders         
Metabolism and Nutrition Disorders   15/444 (3.38%)  15 8/440 (1.82%)  8 16/444 (3.60%)  16 15/443 (3.39%)  15
Nervous system disorders         
Nervous System disorders  1  4/444 (0.90%)  4 5/440 (1.14%)  5 6/444 (1.35%)  6 6/443 (1.35%)  6
Psychiatric disorders         
Psychiatric disorders  1  7/444 (1.58%)  7 8/440 (1.82%)  8 7/444 (1.58%)  7 3/443 (0.68%)  3
Renal and urinary disorders         
Renal and Urinary Disorders  1  1/444 (0.23%)  1 4/440 (0.91%)  4 1/444 (0.23%)  1 4/443 (0.90%)  4
Vascular disorders         
Vascular disorders  1  3/444 (0.68%)  3 5/440 (1.14%)  5 2/444 (0.45%)  2 3/443 (0.68%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AZT+ddI+EFV AZT + ddI + r/LPV d4T + 3TC + EFV d4T + 3TC + r/LPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/444 (0.00%)      0/440 (0.00%)      0/444 (0.00%)      0/443 (0.00%)    
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
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