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Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV

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: NCT00270296
Recruitment Status : Completed
First Posted : December 26, 2005
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Prevention
Condition HIV Infections
Interventions Drug: Trizivir
Drug: Lamivudine/Zidovudine
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Enrollment 730
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TZV Arm Kaletra Arm NVP Arm
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 285 275 170
Completed 186 185 109
Not Completed 99 90 61
Arm/Group Title TZV Arm Kaletra Arm NVP Arm Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 285 275 170 730
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 275 participants 170 participants 730 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
285
 100.0%
275
 100.0%
170
 100.0%
730
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 275 participants 170 participants 730 participants
Female
285
 100.0%
275
 100.0%
170
 100.0%
730
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 285 participants 275 participants 170 participants 730 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
285
 100.0%
275
 100.0%
170
 100.0%
730
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Botswana Number Analyzed 285 participants 275 participants 170 participants 730 participants
285 275 170 730
1.Primary Outcome
Title Number of Participants With Virologic Suppression
Hide Description Suppression of the plasma HIV-1 RNA level to less than 400 copies per milliliter
Time Frame Throughout study, including breastfeeding, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TZV Arm Kaletra Arm NVP Arm
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 285 275 170
Measure Type: Count of Participants
Unit of Measure: Participants
274
  96.1%
256
  93.1%
160
  94.1%
2.Primary Outcome
Title Number of HIV+ Infants
Hide Description Number of infants with HIV-positive status
Time Frame Throughout study, including breastfeeding, assessed up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis is based on actual number of available patients, and may not perfectly match the Patient Flow module.
Arm/Group Title TZV Arm Kaletra Arm NVP Arm
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 283 270 156
Measure Type: Number
Unit of Measure: Infants
6 1 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TZV Arm Kaletra Arm NVP Arm
Hide Arm/Group Description

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

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

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

All-Cause Mortality
TZV Arm Kaletra Arm NVP Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/285 (0.35%)   0/275 (0.00%)   3/170 (1.76%) 
Hide Serious Adverse Events
TZV Arm Kaletra Arm NVP Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   42/285 (14.74%)   32/275 (11.64%)   48/170 (28.24%) 
Blood and lymphatic system disorders       
Grade 3 or 4 Laboratory Event  [1]  42/285 (14.74%)  32/275 (11.64%)  48/170 (28.24%) 
Indicates events were collected by systematic assessment
[1]
Neutropenia or anemia or liver function test (LFT) abnormality
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TZV Arm Kaletra Arm NVP Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/285 (0.00%)   0/275 (0.00%)   0/170 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Roger Shapiro
Organization: Harvard TH Chan School of Public Health
Phone: 617-432-2334
EMail: rshapiro@hsph.harvard.edu
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270296    
Other Study ID Numbers: BHP 016
U01AI064002 ( U.S. NIH Grant/Contract )
First Submitted: December 22, 2005
First Posted: December 26, 2005
Results First Submitted: March 14, 2017
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017