Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

This study has been completed.

First Received: September 12, 2005 Last Updated: September 27, 2007 History of Changes

Sponsor:	Centers for Disease Control and Prevention
Collaborators:	Kamuzu Central Hospital, Lilongwe, Malawi University of North Carolina
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164762

Purpose

The purpose of this study is to determine whether the addition of zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum to single-dose nevirapine (NVP) is associated with a lower prevalence of NVP-resistant HIV compared to single-dose NVP without ZDV+3TC.

Condition
HIV Infections

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Nevirapine

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Enrollment:	126
Study Start Date:	June 2005
Study Completion Date:	November 2006

Detailed Description:

The primary purpose of the Nevirapine Resistance Study is to compare nevirapine (NVP) resistance of HIV at two and six weeks postpartum in women who are participating in two different programs currently ongoing in Lilongwe, Malawi. The first program is through the HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health, also known as the Breastfeeding, Antiretrovirals and Nutrition (BAN) Study, a clinical trial where all enrolled women receive zidovudine (ZDV) and lamivudine (3TC) at the onset of labor and for up to seven days postpartum in addition to single-dose nevirapine (NVP). The second program is the Call to Action (CTA) program sponsored by the Malawi Ministry of Health and Population (MOHP) and UNC Project. The aim of the CTA program is to reduce mother to child transmission (MTCT) of HIV by providing women a single dose NVP to be taken at the onset of labor. Study participants are tested for NVP-resistant HIV at two and six weeks postpartum and the prevalence of NVP-resistant virus is compared among the two groups receiving different peripartum anti-retroviral regimens.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV infected
CD4 count > 200 cells/μL
ALT < 2.5 x upper limit of normal (ULN)
Hemoglobin (Hb) > 7 g/dL
Age > 18 years, or <18 years and married (considered emancipated minors in Malawi)
Ability to give informed consent
Evidence of HIV infection, as documented by 2 positive Enzyme-Linked Immunosorbent Assays (ELISA's); or 1 positive ELISA, and 1 Western blot (WB); or 2 separate concurrent rapid tests. These are the World Health Organization (WHO) acceptable criteria for diagnosing HIV-1 infection in adults.
Currently pregnant (with a single or multiple fetuses)
Gestation < 34 weeks
No serious current complications of pregnancy
Intention to breastfeed
Intention to deliver at the institution in which the study is based
Other than HIV, no active serious infection, such as tuberculosis or other potentially serious illnesses
No previous use of antiretrovirals including the HIVNET 012 regimen

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164762

Locations

Malawi
Area 25 Health Center
Lilongwe, Malawi

Sponsors and Collaborators

Centers for Disease Control and Prevention

Kamuzu Central Hospital, Lilongwe, Malawi

University of North Carolina

Investigators

Principal Investigator:	Sherry L Farr, PhD	Centers for Disease Control and Prevention
Principal Investigator:	Denise J Jamieson, MD, MPH	Centers for Disease Control and Prevention
Principal Investigator:	Charles Van der Horst, MD	The University of North Carolina, Chapel Hill
Principal Investigator:	Peter Kazembe, MB ChB	Kamuzu Central Hospital

More Information

No publications provided

Study ID Numbers:	CDC-NCCDPHP-4535, SIP 26-04
Study First Received:	September 12, 2005
Last Updated:	September 27, 2007
ClinicalTrials.gov Identifier:	NCT00164762 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:

HIV
drug resistance
nevirapine
anti-retroviral drugs

mother-to-child transmission
Treatment Naive
pregnancy

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009