Prevention of Milk-Borne Transmission of HIV-1C in Botswana

Conditions

HIV Infection, Infant Risk for HIV Infection by MTCT

Brief summary

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.

Detailed description

1. 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. 2. To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission. 3. To confirm the safety and tolerance of one dose of NVP given to mothers and infants 4. To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age 5. To determine the association between assigned infant feeding strategy and maternal morbidity and mortality 6. 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.

Scott Dryden‐Peterson, Oluwemimo Jayeoba, Michael D. Hughes, Haruna Jibril, Kenneth McIntosh et al. (11 authors)

PLoS ONE2013-09-2313 citations

10.1371/journal.pone.0074171

Response to antiretroviral therapy after a single, peripartum dose of nevirapine.

Lockman S, Shapiro RL, Smeaton LM, Wester C, Thior I, Stevens L, Chand F, Makhema J, Moffat C, Asmelash A, Ndase P, Arimi P, van Widenfelt E, Mazhani L, Novitsky V, Lagakos S, Essex M.

2007-01-01264 citations

10.1056/nejmoa062876

Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana: a randomized trial: the Mashi Study.

Thior I, Lockman S, Smeaton LM, Shapiro RL, Wester C, Heymann SJ, Gilbert PB, Stevens L, Peter T, Kim S, van Widenfelt E, Moffat C, Ndase P, Arimi P, Kebaabetswe P, Mazonde P, Makhema J, McIntosh K, Novitsky V, Lee TH, Marlink R, Lagakos S, Essex M, Mashi Study Team.

2006-08-01281 citations

10.1001/jama.296.7.794

Interventions

DRUGNevirapine

All women received a background of zidovudine from 34 weeks' gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.

DRUGNo intervention

All women received a background of zidovudine from 34 weeks'gestation through delivery, and all infants received single-dose nevirapine at birth and zidovudine from birth through 1 month. Women were randomized to receive either single-dose nevirapine or placebo during labor.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 45 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
HIV PCR	1 month	The primary endpoint was infant HIV infection by the 1-month visit.

Outcome results

None listed