Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164762
• Other study ID #: CDC-NCCDPHP-4535
• Secondary ID: SIP 26-04
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: September 27, 2007
• Start date: June 2005
• Est. completion date: November 2006

Study information

• Verified date: September 2007
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• HIV Infections

Locations

Country	Name	City	State
Malawi	Area 25 Health Center	Lilongwe

Sponsors (3)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Kamuzu Central Hospital, Lilongwe, Malawi, University of North Carolina

Country where clinical trial is conducted

Malawi,