Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers (PHPT-5)

October 20, 2021 updated by: Marc Lallemant, Institut de Recherche pour le Developpement

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10220
        • Bhumibol Adulyadej Hospital
      • Bangkok, Thailand, 10230
        • Nopparat Rajathanee Hospital
      • Chachoengsao, Thailand, 24000
        • Bhuddasothorn Hospital
      • Chiang Mai, Thailand, 50100
        • Health Promotion Center Region 10, Chiang Mai
      • Kalasin, Thailand, 46000
        • Kalasin Hospital
      • Khon Kaen, Thailand, 40000
        • Khon Kaen hospital
      • Khon Kaen, Thailand, 40000
        • Regional Health Promotion Centre 6, Khon Kaen
      • Lampang, Thailand, 52000
        • Lampang Hospital
      • Lamphun, Thailand, 51000
        • Lamphun Hospital
      • Nakhon Si Thammarat, Thailand, 80000
        • Maharaj Nakhon Si Thammarat Hospital
      • Nong Khai, Thailand, 43000
        • Nong Khai Hospital
      • Nonthaburi, Thailand, 11000
        • Pranangklao Hospital
      • Phayao, Thailand, 56000
        • Phayao Provincial Hospital
      • Phuket, Thailand, 83000
        • Vachira Phuket Hospital
      • Rayong, Thailand, 21000
        • Rayong Hospital
      • Songkhla, Thailand, 90100
        • Songkhla Hospital
    • Chantaburi
      • Chanthaburi, Chantaburi, Thailand, 22000
        • Prapokklao Hospital
    • Chiang Mai
      • Chom Thong, Chiang Mai, Thailand, 50160
        • Chomthong hospital
      • Fang, Chiang Mai, Thailand, 50110
        • Fang Hospital
      • Mae Rim, Chiang Mai, Thailand, 50180
        • Nakornping Hospital
      • San Pa Tong, Chiang Mai, Thailand, 50120
        • Sanpatong Hospital
    • Chiang Rai
      • Mae Chan, Chiang Rai, Thailand, 57110
        • Mae Chan Hospital
      • Phan, Chiang Rai, Thailand, 57120
        • Phan Hospital
    • Chiangrai
      • Chiang Rai, Chiangrai, Thailand, 57000
        • Chiangrai Prachanukroh Hospital
      • Chiang Rai, Chiangrai, Thailand, 57170
        • Wiangpapao Hospital
      • Chiang Saen, Chiangrai, Thailand, 57150
        • Chiang Saen Hospital
    • Chonburi
      • Bang Lamung, Chonburi, Thailand, 20150
        • Banglamung Hospital
      • Chon Buri, Chonburi, Thailand, 20000
        • Chonburi hospital
      • Chon Buri, Chonburi, Thailand, 20140
        • Panasnikom Hospital
    • Mahasarakam
      • Maha Sarakham, Mahasarakam, Thailand, 44000
        • Mahasarakam Hospital
    • Nakhonpathom
      • Nakhon Pathom, Nakhonpathom, Thailand, 73000
        • Nakhonpathom Hospital
    • Phayao
      • Chiang Kham, Phayao, Thailand, 56110
        • Chiang Kham Hospital
    • Pitsanuloke
      • Phitsanulok, Pitsanuloke, Thailand, 65000
        • Buddhachinaraj Hospital
    • Samutprakarn
      • Samut Prakan, Samutprakarn, Thailand, 10280
        • Samutprakarn Hospital
    • Samutsakhon
      • Samut Sakhon, Samutsakhon, Thailand, 74000
        • Samutsakhon Hospital
    • Songkla
      • Hat Yai, Songkla, Thailand, 90110
        • Hat Yai hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Perinatal intensification

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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Up to 12 Months
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).
Up to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherche pour le Developpement

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Harvard School of Public Health (HSPH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Lallemant, MD, Institut de Recherche pour le Developpment

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHPT-5 Second Phase
  • R01HD052461 (U.S. NIH Grant/Contract)
  • R01HD056953 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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