Status:
COMPLETED
Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Kamuzu Central Hospital
University of North Carolina
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
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 ass...
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 current...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00164762
Start Date
June 1 2005
End Date
November 1 2006
Last Update
October 1 2007
Active Locations (1)
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1
Area 25 Health Center
Lilongwe, Malawi