Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

This study has been completed.
Kamuzu Central Hospital, Lilongwe, Malawi
University of North Carolina
Information provided by:
Centers for Disease Control and Prevention Identifier:
First received: September 12, 2005
Last updated: September 27, 2007
Last verified: September 2007

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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi

Resource links provided by NLM:

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00164762

Area 25 Health Center
Lilongwe, Malawi
Sponsors and Collaborators
Kamuzu Central Hospital, Lilongwe, Malawi
University of North Carolina
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 University of North Carolina, Chapel Hill
Principal Investigator: Peter Kazembe, MB ChB Kamuzu Central Hospital
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00164762     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-4535, SIP 26-04
Study First Received: September 12, 2005
Last Updated: September 27, 2007
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
drug resistance
anti-retroviral drugs
mother-to-child transmission
Treatment Naive

Additional relevant MeSH terms:
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses processed this record on February 27, 2015