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Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

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ClinicalTrials.gov Identifier: NCT00164762
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 1, 2007
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease
HIV Infections

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 Design

Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Nevirapine Pharmacodynamics and Resistance Among HIV-Infected Mothers in Lilongwe, Malawi
Study Start Date : June 2005
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Nevirapine
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of North Carolina, Chapel Hill
Principal Investigator: Peter Kazembe, MB ChB Kamuzu Central Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00164762     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-4535
SIP 26-04
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 1, 2007
Last Verified: September 2007

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:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Nevirapine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers