Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

Conditions

HIV Infections

Keywords

Nevirapine, Pregnancy, Maternal to Infant transmission, Infant, Breastfeeding, HIV Seronegativity

Brief summary

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.

Detailed description

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.

Rupak Shivakoti, Nikhil Gupte, Nathella Pavan Kumar, Vandana Kulkarni, Usha Balasubramanian et al. (15 authors)

Clinical Infectious Diseases2018-03-2326 citations

10.1093/cid/ciy253

Growth patterns among HIV-exposed infants receiving nevirapine prophylaxis in Pune, India.

Ram M, Gupte N, Nayak U, Kinikar AA, Khandave M, Shankar AV, Sastry J, Bollinger RC, Gupta A, SWEN India and BJMC-JHU Clinical Trials Study Team.

2012-10-318 citations

10.1186/1471-2334-12-282

Nevirapine resistance and breast-milk HIV transmission: effects of single and extended-dose nevirapine prophylaxis in subtype C HIV-infected infants.

Moorthy A, Gupta A, Bhosale R, Tripathy S, Sastry J, Kulkarni S, Thakar M, Bharadwaj R, Kagal A, Bhore AV, Patil S, Kulkarni V, Venkataramani V, Balasubramaniam U, Suryavanshi N, Ziemniak C, Gupte N, Bollinger R, Persaud D.

2009-01-0150 citations

10.1371/journal.pone.0004096

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomised controlled trials.

Six Week Extended-Dose Nevirapine (SWEN) Study Team, Bedri A, Gudetta B, Isehak A, Kumbi S, Lulseged S, Mengistu Y, Bhore AV, Bhosale R, Varadhrajan V, Gupte N, Sastry J, Suryavanshi N, Tripathy S, Mmiro F, Mubiru M, Onyango C, Taylor A, Musoke P, Nakabiito C, Abashawl A, Adamu R, Antelman G, Bollinger RC, Bright P, Chaudhary MA, Coberly J, Guay L, Fowler MG, Gupta A, Hassen E, Jackson JB, Moulton LH, Nayak U, Omer SB, Propper L, Ram M, Rexroad V, Ruff AJ, Shankar A, Zwerski S.

2008-07-01183 citations

10.1016/s0140-6736(08)61114-9

Interventions

DRUGNevirapine and mulitvitamins

Mothers: One dose of intrapartum nevirapine by mouth (200mg) at onset of labor Infants: One dose of liquid nevirapine by mouth within 72 hours of birth (2mg/kg) Infants: Liquid multivitamins (1ml/day) week 1 through week 6 post-partum Infants (Arm 2 Only): Liquid nevirapine (5 mg/day) by mouth, from week 1 through week 6 post-partum

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame
HIV infection rate of infants	6 months of age
Safety of the regimens for HIV-infected mothers and their breast-fed infants	Through 12 months post-partum

Secondary

Measure	Time frame
Maternal ZDV and NVP resistance	Baseline and post-partum
Infant morbidity and mortality by treatment arm	Until 12 months post partum
Infant NVP resistance by treatment arm	Up to 12 months post partum
Infant NVP pharmacokinetics	Up to 12 months post-partum
Time to HIV infection by treatment regimen	over 12 months of age
Acceptability and compliance of intervention regimens	Until 6 weeks of age
Maternal NVP pharmacokinetics	Up to 12 months post-partum
Time to infection by infant feeding practice and time to weaning	Until 12 months post-partum

Countries

India

Outcome results

None listed