Status:
COMPLETED
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Harvard School of Public Health (HSPH)
Conditions:
HIV Infections
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child transmission (MTCT) of HIV in developed countries. However, little is known of the effectiveness of such re...
Detailed Description
While perinatal HIV infection has become rare in developed countries through the use of highly active antiretroviral therapy (HAART), it remains a serious problem in developing countries. Botswana has...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Mothers:
- HIV-infected
- At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy (observational group) but not beyond the 34th week of pregnancy
- Able to complete study visits until at least 6 months postpartum
- Citizen of Botswana
- Exclusion Criteria for Mothers:
- Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy. Women who have received single-dose NVP in a prior pregnancy are not excluded.
- Certain abnormal laboratory values
- Plan to formula feed
- Known fetal abnormalities that suggest the fetus will not survive to 6 months of gestational age
- Known allergy or medical contraindication to any of the study drugs
- Require certain medications
- Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in Botswana" (Mashi) study
- Currently incarcerated
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
730 Patients enrolled
Trial Details
Trial ID
NCT00270296
Start Date
June 1 2006
End Date
September 1 2010
Last Update
November 2 2021
Active Locations (4)
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1
Princess Marina Hosp., BHP Study Clinic, Gaborone Shapiro CRS
Gaborone, Botswana
2
Athlone Hosp., BHP Study Clinic, Lobatse Shapiro CRS
Lobatse, Botswana
3
Deborah Reteif Hosp., BHP Study Clinic, Mochudi Shapiro CRS
Mochudi, Botswana
4
Scottish Livingstone Hosp., BHP Study Clinic, Molepolole Shapiro CRS
Molepolole, Botswana