Prevention of Milk-Borne Transmission of HIV-1C in Botswana (Mashi)

President and Fellows of Harvard College

Status

Completed

Conditions

Infant Risk for HIV Infection by MTCT

HIV Infection

Treatments

Drug: No intervention

Drug: Nevirapine

Study type

Interventional

Funder types

Other

Identifiers

HSC 10411/9912BOTS

Details and patient eligibility

About

The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.

Full description

To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to Zidovudine (ZDV, also known as AZT) as used in the Botswana mother-to-child transmission (MTCT) National Program, in reducing transmission of HIV-1 from mother to child. To determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child.
To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission.
To confirm the safety and tolerance of one dose of NVP given to mothers and infants
To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
To determine the association between assigned infant feeding strategy and maternal morbidity and mortality
To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment, among HIV+ women who previously received single dose NVP versus placebo during labour.

Enrollment

1,200 patients

Sex

Female

Ages

15 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.