Status:
COMPLETED
Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV-1
Eligibility:
FEMALE
Brief Summary
This study, conducted in Tamil Nadu, India, was initiated in response to the developing epidemic of HIV/AIDS in India. It is divided into two stages, as follows: Stage I All women registered in the ...
Detailed Description
This study is divided into two stages. In Stage I, all women registered in the antenatal clinics at the Namakkal District Hospital or at the Rasipuram Government Hospital in the state of Tamil Nadu in...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Stage I:
- Registration in the Antenatal Clinics, Namakkal District Hospital or Rasipuram Government Hospital.
- Stage II:
- Registration in the Antenatal Clinics, Namakkal District Hospital or Rasipuram Government Hospital.
- Receipt of voluntary HIV counseling.
- Signed informed consent for HIV testing.
- Completion of HIV testing.
- Confirmation of HIV infection (documented by ELISA and Western Blot reports) if rapid test result is positive.
- Receipt of results of HIV testing.
- Age 18 years or more.
- Residence in Namakkal District, Tamil Nadu.
- Confirmation of pregnancy based upon history (last menstrual period) and/or physical examination (documented by a physician's statement in the medical record) and/or ultrasound.
- Willingness and intent to be followed at the antenatal clinic or by home visits for 1year after delivery.
- Signed informed consent by the HIV-infected woman for maternal and infant enrollment into prospective cohort study before onset of labor.
- INCLUSION CRITERIA FOR MATERNAL Zidovudine ADMINISTRATION:
- Enrollment in the prospective cohort study between 24 and 32 weeks.
- Between 28 and 36 weeks gestation at initiation of protocol ZDV.
- Signed informed consent by the father of the HIV-infected woman's unborn child.
- Stated intention to deliver at Namakkal District Hospital or Rasipuram Government Hospital.
- Laboratory criteria (ascertained within 30 days before initial dispensation of the drug).
- Hematology-a) Hemoglobin concentration greater than or equal to 8 grams per deciliter.; b) Absolute neutrophil count greater than or equal to 1000 cells per cubic millimeter; c) Platelet count greater than or equal to 75,000 cells per cubic millimeter.
- Serum chemistries - a) AST (SGOT) less than 92.5 Units per liter; b) ALT (SGPT) less than 100 Units per liter; c) Creatinine concentration less than 2.1 milligrams per deciliter.
- Urinalysis - Urine protein less than 2+ by dipstick test.
- INCLUSION CRITERIA FOR INFANT PROTOCOL ZDV ADMINISTRATION:
- Mother enrolled in the prospective cohort study.
- At least 36 weeks gestation.
- Signed informed consent by the father.
- Delivered at Namakkal District Hospital or Rasipuram Government Hospital.
- EXCLUSION CRITERIA:
- Stage II
- Clinical - Diagnosis of pre-eclampsia.
- Failure to meet all inclusion criteria.
- EXCLUSION CRITERIA FOR INFANT PROTOCOL ZDV ADMINISTRATION:
- Clinical - severe congenital malformations or other condition(s) not compatible with life; Documented or suspected serious infectious, cardiac, respiratory, or metabolic illness, or other immediate life threatening condition making the infant unable to tolerate oral medication beginning the first 24 hours of life.
- Laboratory - Hemoglobin of less than 13 grams per deciliter.
- Failure to meet all inclusion criteria.
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
OBSERVATIONAL
End Date :
August 1 2006
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00341796
Start Date
June 1 2002
End Date
August 1 2006
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892