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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 regimens in developing countries, such as Botswana. This study will determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV) is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected pregnant women in Botswana.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Harvard School of Public Health; Harvard School of Public Health (HSPH)
• Treatments: Abacavir; Lamivudine; Lamivudine, zidovudine drug combination; Lopinavir; Nevirapine; Ritonavir; Zidovudine

Criteria

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