Trial Outcomes & Findings for Antiretroviral Therapy for Advanced HIV Disease in South Africa (NCT NCT00342355)
NCT ID: NCT00342355
Last Updated: 2013-05-21
Results Overview
Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1771 participants
Primary outcome timeframe
January 2004 until March 31 2008
Results posted on
2013-05-21
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
444
|
440
|
444
|
443
|
|
Overall Study
COMPLETED
|
444
|
440
|
444
|
443
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antiretroviral Therapy for Advanced HIV Disease in South Africa
Baseline characteristics by cohort
| Measure |
AZT+ddI+EFV
n=444 Participants
Zidovudine + Didanosine+Efavirenz
|
AZT + ddI + r/LPV
n=440 Participants
Zidovudine + Didanosine + Lopinavir \[LPV\] co-formulated with ritonavir \[RTV\]
|
d4T + 3TC + EFV
n=444 Participants
Stavudine + Lamivudine + efavirenz
|
d4T + 3TC + r/LPV
n=443 Participants
Stavudine + Lamivudine + lopinavir/ritonavir
|
Total
n=1771 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
35.3 years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
35.5 years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
35.6 years
STANDARD_DEVIATION 5.5 • n=483 Participants
|
35.4 years
STANDARD_DEVIATION 5.4 • n=36 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=93 Participants
|
135 Participants
n=4 Participants
|
144 Participants
n=27 Participants
|
142 Participants
n=483 Participants
|
567.0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
298 Participants
n=93 Participants
|
305 Participants
n=4 Participants
|
300 Participants
n=27 Participants
|
301 Participants
n=483 Participants
|
1204.0 Participants
n=36 Participants
|
|
Region of Enrollment
South Africa
|
444 participants
n=93 Participants
|
440 participants
n=4 Participants
|
444 participants
n=27 Participants
|
443 participants
n=483 Participants
|
1771.0 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: January 2004 until March 31 2008Progression of disease, AIDS, or death in treatment naive patients with advanced HIV diagnosis will be evaluated in the four randomly assigned regimens.
Outcome measures
| Measure |
AZT+ddI+EFV
n=444 Participants
Zidovudine + Didanosine+Efavirenz
|
AZT + ddI + r/LPV
n=440 Participants
Zidovudine + Didanosine + Lopinavir \[LPV\] co-formulated with ritonavir \[RTV\]
|
d4T + 3TC + EFV
n=444 Participants
Stavudine + Lamivudine + efavirenz
|
d4T + 3TC + r/LPV
n=443 Participants
Stavudine + Lamivudine + lopinavir/ritonavir
|
|---|---|---|---|---|
|
Progression to AIDS or Death in tx naïve Pts With Adv HIV dx in the Four Randomly Assigned Regimens.
|
93 participants
|
77 participants
|
70 participants
|
80 participants
|
SECONDARY outcome
Timeframe: January 2004 until March 31, 2008Safety outcomes in four different randomly assigned regimens
Outcome measures
| Measure |
AZT+ddI+EFV
n=444 Participants
Zidovudine + Didanosine+Efavirenz
|
AZT + ddI + r/LPV
n=440 Participants
Zidovudine + Didanosine + Lopinavir \[LPV\] co-formulated with ritonavir \[RTV\]
|
d4T + 3TC + EFV
n=444 Participants
Stavudine + Lamivudine + efavirenz
|
d4T + 3TC + r/LPV
n=443 Participants
Stavudine + Lamivudine + lopinavir/ritonavir
|
|---|---|---|---|---|
|
Serious Adverse Events
|
73 participant
|
69 participant
|
64 participant
|
60 participant
|
Adverse Events
AZT+ddI+EFV
Serious events: 96 serious events
Other events: 0 other events
Deaths: 0 deaths
AZT + ddI + r/LPV
Serious events: 85 serious events
Other events: 0 other events
Deaths: 0 deaths
d4T + 3TC + EFV
Serious events: 72 serious events
Other events: 0 other events
Deaths: 0 deaths
d4T + 3TC + r/LPV
Serious events: 71 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZT+ddI+EFV
n=444 participants at risk
Zidovudine + Didanosine+Efavirenz
|
AZT + ddI + r/LPV
n=440 participants at risk
Zidovudine + Didanosine + Lopinavir \[LPV\] co-formulated with ritonavir \[RTV\]
|
d4T + 3TC + EFV
n=444 participants at risk
Stavudine + Lamivudine + efavirenz
|
d4T + 3TC + r/LPV
n=443 participants at risk
Stavudine + Lamivudine + lopinavir/ritonavir
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.7%
12/444 • Number of events 12 • 24.7 months
|
2.0%
9/440 • Number of events 9 • 24.7 months
|
1.1%
5/444 • Number of events 5 • 24.7 months
|
0.45%
2/443 • Number of events 2 • 24.7 months
|
|
Gastrointestinal disorders
Gastrointestinal
|
4.7%
21/444 • Number of events 21 • 24.7 months
|
3.4%
15/440 • Number of events 15 • 24.7 months
|
2.3%
10/444 • Number of events 10 • 24.7 months
|
3.4%
15/443 • Number of events 15 • 24.7 months
|
|
General disorders
General Disorders
|
1.6%
7/444 • Number of events 7 • 24.7 months
|
1.4%
6/440 • Number of events 6 • 24.7 months
|
1.6%
7/444 • Number of events 7 • 24.7 months
|
0.68%
3/443 • Number of events 3 • 24.7 months
|
|
Hepatobiliary disorders
Hepatobilary Disorders
|
0.68%
3/444 • Number of events 3 • 24.7 months
|
1.4%
6/440 • Number of events 6 • 24.7 months
|
0.45%
2/444 • Number of events 2 • 24.7 months
|
0.68%
3/443 • Number of events 3 • 24.7 months
|
|
Infections and infestations
Infections and Infestattions
|
3.4%
15/444 • Number of events 15 • 24.7 months
|
3.4%
15/440 • Number of events 15 • 24.7 months
|
2.7%
12/444 • Number of events 12 • 24.7 months
|
2.7%
12/443 • Number of events 12 • 24.7 months
|
|
Injury, poisoning and procedural complications
Injury,poisoning, and procedure complications
|
1.8%
8/444 • Number of events 8 • 24.7 months
|
0.91%
4/440 • Number of events 4 • 24.7 months
|
0.90%
4/444 • Number of events 4 • 24.7 months
|
1.1%
5/443 • Number of events 5 • 24.7 months
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
3.4%
15/444 • Number of events 15 • 24.7 months
|
1.8%
8/440 • Number of events 8 • 24.7 months
|
3.6%
16/444 • Number of events 16 • 24.7 months
|
3.4%
15/443 • Number of events 15 • 24.7 months
|
|
Nervous system disorders
Nervous System disorders
|
0.90%
4/444 • Number of events 4 • 24.7 months
|
1.1%
5/440 • Number of events 5 • 24.7 months
|
1.4%
6/444 • Number of events 6 • 24.7 months
|
1.4%
6/443 • Number of events 6 • 24.7 months
|
|
Psychiatric disorders
Psychiatric disorders
|
1.6%
7/444 • Number of events 7 • 24.7 months
|
1.8%
8/440 • Number of events 8 • 24.7 months
|
1.6%
7/444 • Number of events 7 • 24.7 months
|
0.68%
3/443 • Number of events 3 • 24.7 months
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.23%
1/444 • Number of events 1 • 24.7 months
|
0.91%
4/440 • Number of events 4 • 24.7 months
|
0.23%
1/444 • Number of events 1 • 24.7 months
|
0.90%
4/443 • Number of events 4 • 24.7 months
|
|
Vascular disorders
Vascular disorders
|
0.68%
3/444 • Number of events 3 • 24.7 months
|
1.1%
5/440 • Number of events 5 • 24.7 months
|
0.45%
2/444 • Number of events 2 • 24.7 months
|
0.68%
3/443 • Number of events 3 • 24.7 months
|
Other adverse events
Adverse event data not reported
Additional Information
Michael A Polis, MD, MPH
National Institute of Allergy and Infectious Diseases, Dvision of Clinical Research
Phone: 301-496-8027
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place