This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Antiretroviral Therapy for Advanced HIV Disease in South Africa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Polis, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00342355
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;   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
  Hide 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
  Hide 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
  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
  Hide Serious Adverse Events

Time Frame 24.7 months
Additional Description 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

Serious Adverse Events
    AZT+ddI+EFV   AZT + ddI + r/LPV   d4T + 3TC + EFV   d4T + 3TC + r/LPV
Total, Serious Adverse Events         
# participants affected / at risk   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 †         
# participants affected / at risk   12/444 (2.70%)   9/440 (2.05%)   5/444 (1.13%)   2/443 (0.45%) 
# events   12   9   5   2 
Gastrointestinal disorders         
Gastrointestinal †         
# participants affected / at risk   21/444 (4.73%)   15/440 (3.41%)   10/444 (2.25%)   15/443 (3.39%) 
# events   21   15   10   15 
General disorders         
General Disorders †         
# participants affected / at risk   7/444 (1.58%)   6/440 (1.36%)   7/444 (1.58%)   3/443 (0.68%) 
# events   7   6   7   3 
Hepatobiliary disorders         
Hepatobilary Disorders †         
# participants affected / at risk   3/444 (0.68%)   6/440 (1.36%)   2/444 (0.45%)   3/443 (0.68%) 
# events   3   6   2   3 
Infections and infestations         
Infections and Infestattions † 1         
# participants affected / at risk   15/444 (3.38%)   15/440 (3.41%)   12/444 (2.70%)   12/443 (2.71%) 
# events   15   15   12   12 
Injury, poisoning and procedural complications         
Injury,poisoning, and procedure complications † 1         
# participants affected / at risk   8/444 (1.80%)   4/440 (0.91%)   4/444 (0.90%)   5/443 (1.13%) 
# events   8   4   4   5 
Metabolism and nutrition disorders         
Metabolism and Nutrition Disorders †         
# participants affected / at risk   15/444 (3.38%)   8/440 (1.82%)   16/444 (3.60%)   15/443 (3.39%) 
# events   15   8   16   15 
Nervous system disorders         
Nervous System disorders † 1         
# participants affected / at risk   4/444 (0.90%)   5/440 (1.14%)   6/444 (1.35%)   6/443 (1.35%) 
# events   4   5   6   6 
Psychiatric disorders         
Psychiatric disorders † 1         
# participants affected / at risk   7/444 (1.58%)   8/440 (1.82%)   7/444 (1.58%)   3/443 (0.68%) 
# events   7   8   7   3 
Renal and urinary disorders         
Renal and Urinary Disorders † 1         
# participants affected / at risk   1/444 (0.23%)   4/440 (0.91%)   1/444 (0.23%)   4/443 (0.90%) 
# events   1   4   1   4 
Vascular disorders         
Vascular disorders † 1         
# participants affected / at risk   3/444 (0.68%)   5/440 (1.14%)   2/444 (0.45%)   3/443 (0.68%) 
# events   3   5   2   3 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events


  Limitations and Caveats
  Hide 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