Status:
COMPLETED
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidenc...
Detailed Description
A single dose of nevirapine (SD-NVP) given to an HIV infected pregnant woman in labor followed by a single dose to her infant had been shown to be a simple and effective means of reducing mother-to-ch...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Mothers:
- HIV infected
- Pregnant with a viable fetus
- Between 28 and 38 weeks of pregnancy
- CD4 count greater than 250 cells/mm3 within 30 days prior to study entry
- Able to receive oral ART during labor
- Willing to use acceptable forms of contraception while on study treatment
- Able to provide written informed consent
- Exclusion Criteria for Mothers:
- Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV
- Any ART other than ZDV during a previous pregnancy or the current pregnancy
- Certain medications
- Planning to receive additional ART during the first 8 weeks postpartum
- Planning to breastfeed
- Unlikely to comply with postpartum study requirements, in the opinion of the investigator
- Certain abnormal laboratory values within 30 days prior to study entry
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00109590
Start Date
June 1 2006
End Date
November 1 2009
Last Update
November 5 2021
Active Locations (7)
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1
Bhumibol Adulyadej Hosp. CRS
Saimai, Bangkok, Thailand, 10220
2
Siriraj Hospital Mahidol University CRS
Bangkok, Bangkoknoi, Thailand, 10700
3
Prapokklao Hosp. CRS
Chanthaburi, Thailand, 22000
4
Chiang Mai University Pediatrics-Obstetrics CRS
Chiang Mai, Thailand, 50200