Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Drug: Nevirapine, zidovudine, lamivudine

• Registration Number: NCT01511237
• Lead Sponsor: Institut de Recherche pour le Developpement

Brief Summary

The purpose is to evaluate the efficacy of maternal and infant perinatal antiretroviral prophylaxis intensification for the prevention of mother-to-child intrapartum transmission of HIV-1 in women receiving less than 8 weeks of antiretroviral prophylaxis during pregnancy.

Detailed Description

Design: a multicenter, phase III, single-arm trial.

Perinatal antiretroviral intensification (study treatment) is defined as the addition to the standard of care\* for mothers and infants of:

* Mothers: One NVP 200 mg tablet at onset of labor with continuation of HAART for four weeks postpartum

* Newborn: AZT+3TC+ NVP for 2 weeks, followed by AZT+3TC for 2 weeks:

* NVP syrup 2 mg/kg every 24 hours for seven days, followed by NVP syrup 4 mg/kg every 24 hours for seven days. Newborns less than 2500 g will be administered 2mg/kg NVP syrup at each intake

* AZT syrup 4 mg/ kg will be given every 12 hours for four weeks (preterm infants less than 30 weeks will be administered 2 mg/kg every 12 hours; preterm 30-35 weeks will receive 2 mg/kg every 12 hours for the first 2 weeks, increased to 3 mg/kg for the next 2 weeks).

* 3TC syrup 2 mg/kg every 12 hours for four weeks.

* The standard of care in Thailand is defined as:

* Maternal antiretroviral treatment: ZDV 300 mg, 3TC 150mg and LPV/r 400/100 twice a day starting as soon possible after 14 weeks of pregnancy + ZDV 300 mg every 3 hours during labor; this treatment may be continued, stopped or modified after delivery upon the recommendation of the internist.

* Newborn: ZDV 4 mg/kg every 12 hours for 4 weeks (ZDV dosing adjusted for premature infants).

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-12
• Study First Posted: 2012-01-18
• Primary Completion: 2015-06
• Study Completion: 2017-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 379

Inclusion Criteria

Not provided

Exclusion Criteria

• Evidence of pre-existing fetal anomalies incompatible with life;
• Concurrent participation to any other clinical trial without prior agreement of the two study teams

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perinatal intensification	Nevirapine, zidovudine, lamivudine	Perinatal antiretroviral intensification (study treatment): * Mothers: One NVP 200 mg tablet at onset of labor with continuation of HAART for four weeks postpartum * Newborn: AZT+3TC+ NVP for 2 weeks, followed by AZT+3TC for 2 weeks The standard of care in Thailand is defined as: * Maternal: ZDV 300 mg, 3TC 150mg and LPV/r 400/100 twice a day starting as soon possible after 14 weeks of pregnancy + ZDV 300 mg every 3 hours during labor * Newborn: ZDV 4 mg/kg every 12 hours for 4 weeks (ZDV dosing adjusted for premature infants).

Primary Outcome Measures

Name	Time	Method
Rate of perinatal HIV transmission	6 months	HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age

Secondary Outcome Measures

Name	Time	Method
Safety for women and neonates	Up to 12 Months	All grade 3 and 4 clinical adverse events and abnormal laboratory values in women will be recorded and graded according to the toxicity tables developed by the DAIDS
Pregnancy outcomes	Up to 12 Months	Evaluation of the rates of live births and stillbirths, as well as birth weight, gestational age at delivery according to the results of the sonogram at first prenatal visit, newborn maturity (Ballard score).

Trial Locations

Locations (36)

Samutprakarn Hospital; 🇹🇭 Samut Prakan, Samutprakarn, Thailand

Chiang Kham Hospital; 🇹🇭 Chiang Kham, Phayao, Thailand

Chiangrai Prachanukroh Hospital; 🇹🇭 Chiang Rai, Chiangrai, Thailand

Chiang Saen Hospital; 🇹🇭 Chiang Saen, Chiangrai, Thailand

Nopparat Rajathanee Hospital; 🇹🇭 Bangkok, Thailand

Bhuddasothorn Hospital; 🇹🇭 Chachoengsao, Thailand

Lamphun Hospital; 🇹🇭 Lamphun, Thailand

Panasnikom Hospital; 🇹🇭 Chon Buri, Chonburi, Thailand

Mae Chan Hospital; 🇹🇭 Mae Chan, Chiang Rai, Thailand

Wiangpapao Hospital; 🇹🇭 Chiang Rai, Chiangrai, Thailand

Samutsakhon Hospital; 🇹🇭 Samut Sakhon, Samutsakhon, Thailand

Health Promotion Center Region 10, Chiang Mai; 🇹🇭 Chiang Mai, Thailand

Kalasin Hospital; 🇹🇭 Kalasin, Thailand

Khon Kaen Hospital; 🇹🇭 Khon Kaen, Thailand

Regional Health Promotion Centre 6, Khon Kaen; 🇹🇭 Khon Kaen, Thailand

Songkhla Hospital; 🇹🇭 Songkhla, Thailand

Prapokklao Hospital; 🇹🇭 Chanthaburi, Chantaburi, Thailand

Fang Hospital; 🇹🇭 Fang, Chiang Mai, Thailand

Nakornping Hospital; 🇹🇭 Mae Rim, Chiang Mai, Thailand

Phan Hospital; 🇹🇭 Phan, Chiang Rai, Thailand

Banglamung Hospital; 🇹🇭 Bang Lamung, Chonburi, Thailand

Nakhonpathom Hospital; 🇹🇭 Nakhon Pathom, Nakhonpathom, Thailand

Mahasarakam Hospital; 🇹🇭 Maha Sarakham, Mahasarakam, Thailand

Buddhachinaraj Hospital; 🇹🇭 Phitsanulok, Pitsanuloke, Thailand

Nong Khai Hospital; 🇹🇭 Nong Khai, Thailand

Rayong Hospital; 🇹🇭 Rayong, Thailand

Sanpatong Hospital; 🇹🇭 San Pa Tong, Chiang Mai, Thailand

Chomthong Hospital; 🇹🇭 Chom Thong, Chiang Mai, Thailand

Chonburi Hospital; 🇹🇭 Chon Buri, Chonburi, Thailand

Hat Yai Hospital; 🇹🇭 Hat Yai, Songkla, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Vachira Phuket Hospital; 🇹🇭 Phuket, Thailand

Lampang Hospital; 🇹🇭 Lampang, Thailand

Maharaj Nakhon Si Thammarat Hospital; 🇹🇭 Nakhon Si Thammarat, Thailand

Pranangklao Hospital; 🇹🇭 Nonthaburi, Thailand

Phayao Provincial Hospital; 🇹🇭 Phayao, Thailand