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

HIV Infection Clinical Trial

— Mashi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197587
• Other study ID #: HSC 10411/9912BOTS
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 17, 2013
• Start date: August 2002

Study information

• Verified date: May 2013
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Botswana: Ministry of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infant Risk for HIV Infection by MTCT
• Infection

Intervention

Drug:
• Nevirapine
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.
• No 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Public Health

References & Publications (3)

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. Response to antiretroviral therapy after a single, peripartum dose of — View Citation

Shapiro RL, Thior I, Gilbert PB, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann SJ, Ndung'u T, Gaseitsiwe S, Novitsky V, Makhema J, Lagakos S, Essex M. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mo — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV PCR	The primary endpoint was infant HIV infection by the; 1-month visit.	1 month	No