HIV InfectionsPhase 3PHPT-5NCT01511237
Perinatal Antiretroviral Intensification for PMTCT of HIV in Late Comers
A Phase 3 study testing Nevirapine, zidovudine, lamivudine in people with HIV Infections, run by Institut de Recherche pour le Developpement at 36 sites in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine, zidovudine, lamivudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 36 sitesThailand
- Study dates
- Dec 2011to Mar 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Evidence of pre-existing fetal anomalies incompatible with life;
- Concurrent participation to any other clinical trial without prior agreement of the two study teams
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Thailand36 sites
Banglamung Hospital
Bang Lamung, Changwat Chon Buri, 20150
Bhumibol Adulyadej Hospital
Bangkok, 10220
Nopparat Rajathanee Hospital
Bangkok, 10230
Bhuddasothorn Hospital
Chachoengsao, 24000
Prapokklao Hospital
Chanthaburi, Changwat Chanthaburi, 22000
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, 56110
Health Promotion Center Region 10, Chiang Mai
Chiang Mai, 50100
Chiangrai Prachanukroh Hospital
Chiang Rai, Chiangrai, 57000
Wiangpapao Hospital
Chiang Rai, Chiangrai, 57170
Chiang Saen Hospital
Chiang Saen, Chiangrai, 57150
Chomthong Hospital
Chom Thong, Chiang Mai, 50160
Chonburi Hospital
Chon Buri, Changwat Chon Buri, 20000
Panasnikom Hospital
Chon Buri, Changwat Chon Buri, 20140
Fang Hospital
Fang, Chiang Mai, 50110
Hat Yai Hospital
Hat Yai, Changwat Songkhla, 90110
Kalasin Hospital
Kalasin, 46000
Khon Kaen Hospital
Khon Kaen, 40000
Regional Health Promotion Centre 6, Khon Kaen
Khon Kaen, 40000
Lampang Hospital
Lampang, 52000
Lamphun Hospital
Lamphun, 51000
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, 57110
Nakornping Hospital
Mae Rim, Chiang Mai, 50180
Mahasarakam Hospital
Maha Sarakham, Mahasarakam, 44000
Samutprakarn Hospital
Mueang Samut Prakan, Samutprakarn, 10280
Nakhonpathom Hospital
Nakhon Pathom, Nakhonpathom, 73000
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, 80000
Nong Khai Hospital
Nong Khai, 43000
Pranangklao Hospital
Nonthaburi, 11000
Phan Hospital
Phan, Changwat Chiang Rai, 57120
Phayao Provincial Hospital
Phayao, 56000
Buddhachinaraj Hospital
Phitsanulok, Changwat Phitsanulok, 65000
Vachira Phuket Hospital
Phuket, 83000
Rayong Hospital
Rayong, 21000
Samutsakhon Hospital
Samut Sakhon, Samutsakhon, 74000
Sanpatong Hospital
San Pa Tong, Chiang Mai, 50120
Songkhla Hospital
Songkhla, 90100
About this study
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
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Nevirapine, zidovudine, lamivudine
- Keywords
- HIV-1 infection, Prophylaxis, Mother-to-child transmission HIV-1, Thailand, Developing Countries
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevirapine, zidovudine, lamivudineDrug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Perinatal intensification | Experimental | 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). Receives: Drug: Nevirapine, zidovudine, lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of perinatal HIV transmission
HIV DNA PCR analysis at birth, 2 weeks, 1, 2, 4 and 6 months of age
Measured: 6 months
Secondary outcomes (2)
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
Measured: Up to 12 Months
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).
Measured: Up to 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Marc Lallemant, Institut de Recherche pour le Developpement
- Investigators
- Marc Lallemant, MD, Principal investigator, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511237
- Sponsor's protocol ID
- PHPT-5 Second Phase
- Other IDs
- R01HD052461, R01HD056953
- Acronym
- PHPT-5
- Status last verified
- Oct 2021
- First submitted
- 10 Jan 2012
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28489732Lallemant Marc, Amzal Billy, Urien Saik, Sripan Patumrat, Cressey Tim R, Ngo-Giang-Huong Nicole, Rawangban Boonsong, Sabsanong Prapan, Siriwachirachai Thitiporn, Jarupanich Tapnarong, Kanjanavikai Prateep, Wanasiri Phaiboon, Koetsawang Suporn, Jourdain Gonzague, Le Cœur Sophie, for the PHPT-5 team. 2015. -"Antiretroviral Intensification to Prevent Intrapartum HIV Transmission in Late Comers". 8th IAS Conference on HIV Pathogenesis Treatment & Prevention, Vancouver, Canada, 19-22 July 2015.
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 Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):313-322. doi: 10.1097/QAI.0000000000002350.
PubMed 32205720
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01511237
- Acronym / sponsor ID
- PHPT-5 / PHPT-5 Second Phase
- Conditions
- HIV Infections
- Keywords
- HIV-1 infection, Prophylaxis, Mother-to-child transmission HIV-1, Thailand, Developing Countries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Harvard School of Public Health (HSPH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perinatal intensification | Experimental | Drug: Nevirapine, zidovudine, lamivudinePerinatal 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Evidence of pre-existing fetal anomalies incompatible with life;
- Concurrent participation to any other clinical trial without prior agreement of the two study teams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Perinatal intensification |
Primary outcome
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
2 secondary outcomes
Safety for women and neonates
Time frame: Up to 12 Months
Pregnancy outcomes
Time frame: Up to 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Background: PubMed 28489732Cressey 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.
- Results publicationLallemant Marc, Amzal Billy, Urien Saik, Sripan Patumrat, Cressey Tim R, Ngo-Giang-Huong Nicole, Rawangban Boonsong, Sabsanong Prapan, Siriwachirachai Thitiporn, Jarupanich Tapnarong, Kanjanavikai Prateep, Wanasiri Phaiboon, Koetsawang Suporn, Jourdain Gonzague, Le Cœur Sophie, for the PHPT-5 team. 2015. -"Antiretroviral Intensification to Prevent Intrapartum HIV Transmission in Late Comers". 8th IAS Conference on HIV Pathogenesis Treatment & Prevention, Vancouver, Canada, 19-22 July 2015.
- Results publication: PubMed 32205720Lallemant 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 Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery. J Acquir Immune Defic Syndr. 2020 Jul 1;84(3):313-322. doi: 10.1097/QAI.0000000000002350.
- PHPT-5 First PhaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Lallemant, MD principal investigator
Institut de Recherche pour le Developpement
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nevirapine, zidovudine, lamivudine in people with HIV Infections, run by Institut de Recherche pour le Developpement at 36 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of perinatal HIV transmission (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511237, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.