Trial Outcomes & Findings for Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV (NCT NCT00270296)
NCT ID: NCT00270296
Last Updated: 2021-11-02
Results Overview
Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
730 participants
Primary outcome timeframe
Throughout study, including breastfeeding, assessed up to 24 months
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
TZV Arm
Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
|
Kaletra Arm
Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
|
NVP Arm
Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
285
|
275
|
170
|
|
Overall Study
COMPLETED
|
186
|
185
|
109
|
|
Overall Study
NOT COMPLETED
|
99
|
90
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Baseline characteristics by cohort
| Measure |
TZV Arm
n=285 Participants
Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
|
Kaletra Arm
n=275 Participants
Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
|
NVP Arm
n=170 Participants
Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
|
Total
n=730 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
285 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
730 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
285 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
730 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
285 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
730 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Botswana
|
285 participants
n=5 Participants
|
275 participants
n=7 Participants
|
170 participants
n=5 Participants
|
730 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Throughout study, including breastfeeding, assessed up to 24 monthsSuppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter
Outcome measures
| Measure |
TZV Arm
n=285 Participants
Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
|
Kaletra Arm
n=275 Participants
Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
|
NVP Arm
n=170 Participants
Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
|
|---|---|---|---|
|
Number of Participants With Virologic Suppression
|
274 Participants
|
256 Participants
|
160 Participants
|
PRIMARY outcome
Timeframe: Throughout study, including breastfeeding, assessed up to 24 monthsPopulation: Analysis is based on actual number of available patients, and may not perfectly match the Patient Flow module.
Number of infants with HIV-positive status
Outcome measures
| Measure |
TZV Arm
n=283 Participants
Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
|
Kaletra Arm
n=270 Participants
Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
|
NVP Arm
n=156 Participants
Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
|
|---|---|---|---|
|
Number of HIV+ Infants
|
6 Infants
|
1 Infants
|
1 Infants
|
Adverse Events
TZV Arm
Serious events: 42 serious events
Other events: 0 other events
Deaths: 1 deaths
Kaletra Arm
Serious events: 32 serious events
Other events: 0 other events
Deaths: 0 deaths
NVP Arm
Serious events: 48 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
TZV Arm
n=285 participants at risk
Participants in Arm 1A will have CD4 counts of 200 cells/mm3 or more and will receive TZV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Trizivir: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
|
Kaletra Arm
n=275 participants at risk
Participants in Arm 1B will have CD4 counts of 200 cells/mm3 or more and will receive LPV/RTV and 3TC/ZDV twice daily. Once in labor, these participants will continue to take TZV twice daily and will also be given additional ZDV.
Lamivudine/Zidovudine: 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily
Lopinavir/Ritonavir: 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily
|
NVP Arm
n=170 participants at risk
Participants in Arm 2 will have CD4 counts less than 200 cells/mm3 and will receive NVP once daily for the first 14 days, then twice daily, and 3TC/ZDV twice daily; these women will be in the observational group.
Nevirapine: 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Grade 3 or 4 Laboratory Event
|
14.7%
42/285
|
11.6%
32/275
|
28.2%
48/170
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Roger Shapiro
Harvard TH Chan School of Public Health
Phone: 617-432-2334
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place