BJ Medical college Pune: HIV- MTCT Trial

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Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases

(NIAID)

Purpose

Infants who are breast-fed by HIV infected mothers have an increased

risk of becoming infected with HIV. Standard therapy for the

prevention of HIV infections in infants included zidovudine (ZDV)

prior to the onset of labor, a single dose of nevirapine (NVP) for

women during labor, and a single dose of NVP for newborns given 72

hours after birth. This study will determine if giving low dose daily

NVP to breastfed infants of HIV infected mothers, in addition to

standard therapy, will be more effective than standard therapy alone

at preventing HIV infections in these infants.

Condition Treatment or Intervention Phase

HIV Infections, Drug: Nevirapine

Phase III

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control,

Parallel Assignment, Safety/Efficacy Study

Official Title: Prevention of Maternal to Infant HIV Transmission in

India

Further Study Details:

This study will evaluate the safety and effectiveness of adding daily

infant NVP to standard prevention measures to decrease vertical

transmission of HIV.

According to current statistics from the study site, approximately

70% of the pregnant HIV infected women in this study will have begun

antenatal ZDV prior to the initiation of NVP at labor. The remaining

30% of the HIV infected women enrolled in this trial will have been

previously undiagnosed. These women will be diagnosed with HIV

infection either at the time they present to the delivery room in

stage 1 of labor or immediately postpartum if they present for

delivery late in labor and cannot provide informed consent for HIV

screening prior to delivery.

All infants will receive the standard does of NVP at 72 hours

postpartum. Infants will then be randomized to receive either daily

NVP and a daily multivitamin (MVI) or a daily MVI alone. Infants will

take NVP/MVI or MVI alone during Weeks 2 to 6 postpartum. The primary

outcome measure is infant HIV infection rates at 6 months.

Two additional related cohorts of women will be followed for

comparison: 1) an equal number of HIV uninfected women and their

children will be enrolled for comparison of postpartum morbidity and

mortality; and 2) consenting HIV infected women and their children

who choose not to enroll in the clinical trial or are ineligible

because they are not breastfeeding will be enrolled in an ancillary

cohort.

Eligibility

Ages Eligible for Study: 18 Years and above , Genders Eligible for

Study: Female

Criteria

Inclusion Criteria for Pregnant or Postpartum Mothers

HIV infected

Planning to breastfeed

Able to tolerate oral drugs and available for 12 months of postpartum

follow-up

Exclusion Criteria

Significant physical or emotional distress

Infant with serious or life threatening disease or severe fetal

abnormality

Obstetrical complications affecting maternal health

Prior antiretroviral drugs (except antenatal ZDV or intrapartum NVP)

Expected Total Enrollment: 1800

Location and Contact Information

C Bollinger, MD, MPH 410-614-0936 rcb@...

India. BJ Medical College, Pune, India; Recruiting

Mridula Phadke, MD 91-20-553-8962 drmapaa@...

C Bollinger, MD 001-410-614-0936 rcb@...

Study chairs or principal investigators

C Bollinger, MD, MPH, Principal Investigator, s Hopkins

University

Publications

Bhore AV, Sastry J, Patke D, Gupte N, Bulakh PM, Lele S, Karmarkar A,

Bharucha KE, Shrotri A, Pisal H, Suryawanshi N, Tripathy S, Risbud

AR, Paranjape RS, Shankar AV, Kshirsagar A, Phadke MA, Joshi PL,

Brookmeyer RS, Bollinger RC Jr. Sensitivity and specificity of rapid

HIV testing of pregnant women in India. Int J STD AIDS. 2003 Jan;14

(1):37-41.

Study ID Numbers 5R01AI045462-04

Study Start Date August 2002; Estimated Completion Date May 2007

Record last reviewed May 2003

NLM Identifier NCT00061321

ClinicalTrials.gov processed this record on 2003-05-30