Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers

HIV Infections Clinical Trial

— PHPT-5  

Official title:

PHPT-5 Second Phase: Perinatal Antiretroviral Intensification for the Prevention of Mother-to-child Transmission of HIV in Thai Women Having Received Less Than 8 Weeks of HAART During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511237
• Other study ID #: PHPT-5 Second Phase
• Secondary ID: R01HD052461R01HD
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: March 2017

Study information

• Verified date: October 2021
• Source: Institut de Recherche pour le Developpement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: March 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Eligibility. Pregnant women presenting at the prenatal clinics will be eligible if they are confirmed HIV-infected, intend to deliver and bring their infant to a study site for postnatal care for at least 6 months; at least 18 years old; and have given written informed consent to participate in the study, regardless of their CD4 cell count.

Maternal inclusion criteria:

• Evidence of HIV infection, as documented by two serology tests obtained at two different dates;

• All HIV infected pregnant women will be enrolled, either in the intervention arm or an observational study group.

• Women more than 30 weeks gestational age at start of antiretroviral treatment will be eligible for the intervention. They will actually receive the study intervention if they present in labor after less than 8 weeks of treatment duration;

• Women with no ANC will receive standard care and will be enrolled in an observational study group(and their infant will receive standard of care perinatal antiretroviral intensification)

• Women with less than 30 weeks gestational age at start of treatment will receive standard care and will also be enrolled in the Observational Reference group;

• Agreement not to breastfeed;

• Consent to participate and to be followed for the duration of the study

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

Related Conditions & MeSH terms

• HIV Infections
• Infections

Intervention

Drug:
• Nevirapine, zidovudine, lamivudine
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.

Locations

Country	Name	City	State
Thailand	Banglamung Hospital	Bang Lamung	Chonburi
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Nopparat Rajathanee Hospital	Bangkok
Thailand	Bhuddasothorn Hospital	Chachoengsao
Thailand	Prapokklao Hospital	Chanthaburi	Chantaburi
Thailand	Chiang Kham Hospital	Chiang Kham	Phayao
Thailand	Health Promotion Center Region 10, Chiang Mai	Chiang Mai
Thailand	Chiangrai Prachanukroh Hospital	Chiang Rai	Chiangrai
Thailand	Wiangpapao Hospital	Chiang Rai	Chiangrai
Thailand	Chiang Saen Hospital	Chiang Saen	Chiangrai
Thailand	Chomthong Hospital	Chom Thong	Chiang Mai
Thailand	Chonburi Hospital	Chon Buri	Chonburi
Thailand	Panasnikom Hospital	Chon Buri	Chonburi
Thailand	Fang Hospital	Fang	Chiang Mai
Thailand	Hat Yai Hospital	Hat Yai	Songkla
Thailand	Kalasin Hospital	Kalasin
Thailand	Khon Kaen Hospital	Khon Kaen
Thailand	Regional Health Promotion Centre 6, Khon Kaen	Khon Kaen
Thailand	Lampang Hospital	Lampang
Thailand	Lamphun Hospital	Lamphun
Thailand	Mae Chan Hospital	Mae Chan	Chiang Rai
Thailand	Nakornping Hospital	Mae Rim	Chiang Mai
Thailand	Mahasarakam Hospital	Maha Sarakham	Mahasarakam
Thailand	Nakhonpathom Hospital	Nakhon Pathom	Nakhonpathom
Thailand	Maharaj Nakhon Si Thammarat Hospital	Nakhon Si Thammarat
Thailand	Nong Khai Hospital	Nong Khai
Thailand	Pranangklao Hospital	Nonthaburi
Thailand	Phan Hospital	Phan	Chiang Rai
Thailand	Phayao Provincial Hospital	Phayao
Thailand	Buddhachinaraj Hospital	Phitsanulok	Pitsanuloke
Thailand	Vachira Phuket Hospital	Phuket
Thailand	Rayong Hospital	Rayong
Thailand	Samutprakarn Hospital	Samut Prakan	Samutprakarn
Thailand	Samutsakhon Hospital	Samut Sakhon	Samutsakhon
Thailand	Sanpatong Hospital	San Pa Tong	Chiang Mai
Thailand	Songkhla Hospital	Songkhla

Sponsors (3)

Lead Sponsor	Collaborator
Institut de Recherche pour le Developpement	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Harvard School of Public Health (HSPH)

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Cressey TR, Punyawudho B, Le Coeur S, Jourdain G, Saenjum C, Capparelli EV, Jittayanun K, Phanomcheong S, Luvira A, Borkird T, Puangsombat A, Aarons L, Sukrakanchana PO, Urien S, Lallemant M; PHPT-5 study team. Assessment of Nevirapine Prophylactic and Therapeutic Dosing Regimens for Neonates. J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):554-560. doi: 10.1097/QAI.0000000000001447. — View Citation

Lallemant M, Amzal B, Sripan P, Urien S, Cressey TR, Ngo-Giang-Huong N, Klinbuayaem V, Rawangban B, Sabsanong P, Siriwachirachai T, Jarupanich T, Kanjanavikai P, Wanasiri P, Koetsawang S, Jourdain G, Le Coeur S; PHPT-5 site investigators. Perinatal Antire — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of perinatal HIV transmission	HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age	6 months
Secondary	Safety for women and neonates	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	Up to 12 Months
Secondary	Pregnancy outcomes	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).	Up to 12 Months

External Links

•   PHPT-5 First Phase