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

Sponsored by:	Harvard School of Public Health
Information provided by:	Harvard School of Public Health
ClinicalTrials.gov Identifier:	NCT00197587

Purpose

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.

Condition	Intervention
HIV Infection Infant Risk for HIV Infection by MTCT	Drug: Nevirapine

MedlinePlus related topics: AIDS

Drug Information available for: Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Factorial Assignment

Further study details as provided by Harvard School of Public Health:

Estimated Enrollment:

1200

Detailed 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 feedign on HIV transmission.
To confirm the safety and tolerance of one dose of NVP given to mothers and infants
To evaluate the safety and teolerance of AZT agiven to infants for up to 6 months of age
To determine the association be. 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.

Eligibility

Ages Eligible for Study:	15 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197587

Locations

Botswana
Princess Marina Hospital
Gabarone, Botswana

Sponsors and Collaborators

Harvard School of Public Health

Investigators

Study Chair:

Myron Essex, DVM,PhD

Harvard School of Public Health

More Information

Publications of Results:

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. 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. JAMA. 2006 Aug 16;296(7):794-805.

Publications indexed to this study:

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 nevirapine. N Engl J Med. 2007 Jan 11;356(2):135-47.

Study ID Numbers:	HSC 10411/9912BOTS
Study First Received:	September 12, 2005
Last Updated:	September 28, 2006
ClinicalTrials.gov Identifier:	NCT00197587
Health Authority:	Botswana: Ministry of Health; United States: Federal Government

Study placed in the following topic categories:

Virus Diseases
Nevirapine
Sexually Transmitted Diseases, Viral
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Anti-HIV Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009