Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers (PHPT-5)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01511237|
Recruitment Status : Unknown
Verified November 2016 by Marc Lallemant, Institut de Recherche pour le Developpement.
Recruitment status was: Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : November 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Nevirapine, zidovudine, lamivudine||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1837 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||March 2017|
Experimental: Perinatal intensification
Perinatal antiretroviral intensification (study treatment):
The standard of care in Thailand is defined as:
Drug: Nevirapine, zidovudine, lamivudine
- Rate of perinatal HIV transmission [ Time Frame: 6 months ]HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age
- Safety for women and neonates [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511237
|Principal Investigator:||Marc Lallemant, MD||Institut de Recherche pour le Developpment|