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

This study has been completed.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00270296
First received: December 22, 2005
Last updated: April 27, 2017
Last verified: April 2017
Results First Received: March 14, 2017  
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

  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
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


Participant Flow:   Overall Study
    TZV Arm   Kaletra Arm   NVP Arm
STARTED   285   275   170 
COMPLETED   186   185   109 
NOT COMPLETED   99   90   61 



  Baseline Characteristics
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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
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

Total Total of all reporting groups

Baseline Measures
   TZV Arm   Kaletra Arm   NVP Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 285   275   170   730 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
       
Botswana   285   275   170   730 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Virologic Suppression   [ Time Frame: Throughout study, including breastfeeding, assessed up to 24 months ]

2.  Primary:   Number of HIV+ Infants   [ Time Frame: Throughout study, including breastfeeding, assessed up to 24 months ]


  Serious Adverse Events


  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
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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: Dr. Roger Shapiro
Organization: Harvard TH Chan School of Public Health
phone: 617-432-2334
e-mail: rshapiro@hsph.harvard.edu


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270296     History of Changes
Other Study ID Numbers: BHP 016
U01AI064002 ( U.S. NIH Grant/Contract )
Study First Received: December 22, 2005
Results First Received: March 14, 2017
Last Updated: April 27, 2017