Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 27, 2007

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00164762 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

Official Title ^ICMJE

Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Natural History, Longitudinal, Defined Population, Prospective Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

126

Completion Date

November 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Malawi

Administrative Information

NCT ID ^ICMJE

NCT00164762

Responsible Party

Study ID Numbers ^ICMJE

CDC-NCCDPHP-4535, SIP 26-04

Study Sponsor ^ICMJE

Centers for Disease Control and Prevention

Collaborators ^ICMJE

Kamuzu Central Hospital, Lilongwe, Malawi
University of North Carolina

Investigators ^ICMJE

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

Information Provided By

Centers for Disease Control and Prevention

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP