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HIV InfectionsPhase 3PHPT-5NCT00409591

Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand

A Phase 3 study testing Maternal and infant nevirapine, Maternal lopinavir+ritonavir and zidovudine in people with HIV Infections and Pregnancy, run by Institut de Recherche pour le Developpement at 43 sites in Thailand.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and… Read more about this study

Who is it for?
Any age
Conditions the study is for
HIV Infections, Pregnancy
What is being tested?
Maternal and infant nevirapine, Maternal lopinavir+ritonavir and zidovudine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
435 participants
Where
43 sitesThailand
Study dates
Jul 2008to Jun 2015
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Women are eligible for the study if they
  • met all pre-entry criteria
  • Evidence of HIV infection, as documented by two serology tests obtained at two different dates;
  • between 28 and 36 weeks gestational age;
  • antiretroviral naïve except for exposure to ZDV prophylaxis PMTCT;
  • CD4 count above 250 cells/mm3 (within 4 months prior to randomization)
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  • agreement not to breastfeed;
  • consent to participate and to be followed for the duration of the study;
  • and the following laboratory values within 14 days prior to randomization:
  • hemoglobin > 8.5 mg/dl;
  • absolute neutrophil count > 750 cells/mm3;
  • platelets > 50,000 cells/mm3;
  • SGPT ≤ 5 times upper limit of normal;
  • serum creatinine ≤ 1.5 times upper limit of normal (women with a serum creatinine > 1.5 times upper limit of normal must have a measured eight-hour urine creatinine clearance > 70 ml/min).

Who cannot join

  • Evidence of pre-existing fetal anomalies incompatible with life;
  • patients who meet the criteria of Classes III/IV of the WHO classification of HIV-associated clinical disease;
  • known hypersensitivity to any benzodiazepine;
  • active tuberculosis;
  • concurrent participation to any other clinical trial;
  • receipt of benzodiazepines or antiretroviral agent other than ZDV;
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  • uncontrolled hypertension;
  • anticoagulant therapy or magnesium sulfate within 2 weeks of enrollment or the need for them during labor or at delivery.
  • If any of these conditions occurs after randomization, the women will be excluded from study drug dosing. Women with CD4 count lower than 250 cells/mm3 will be excluded from the study and offered HAART in the context of the national program.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

Thailand43 sites

  • Banglamung Hospital

    Bang Lamung, Changwat Chon Buri, 20150

  • Health Promotion Hospital Regional Center I

    Bangkok, Bangkok, 10220

  • Chiang Kham Hospital

    Chiang Kham, Changwat Phayao, 56110

  • Health Promotion Center Region 10,

    Chiang Mai, Chiang Mai, 50100

  • Fang Hospital

    Chiang Mai, 50110

  • Chomthong Hospital

    Chiang Mai, 50160

  • Chiang Saen Hospital

    Chiang Saen, Chiangrai, 57150

  • Somdej Pranangchao Sirikit Hospital

    Chon Buri, Changwat Chon Buri, 20180

  • Hat Yai Hospital

    Hat Yai, Changwat Songkhla, 90110

  • Nopparat Rajathanee Hospital

    Kannayao, Bangkok, 10230

  • Regional Health Promotion Centre 6,

    Khon Kaen, Changwat Khon Kaen, 40000

  • Lampang Hospital

    Lampang, Changwat Lampang, 52000

  • Lamphun Hospital

    Lamphun, Changwat Lamphun, 51000

  • Mae Chan Hospital

    Mae Chan, Changwat Chiang Rai

  • Nakornping Hospital

    Mae Rim, Chiang Mai, 50180

  • Mae Sai Hospital

    Mae Sai, Changwat Chiang Rai

  • Chachoengsao Hospital

    Muang, Changwat Chachoengsao, 24000

  • Prapokklao Hospital

    Muang, Changwat Chanthaburi, 22000

  • Chonburi Hospital

    Muang, Changwat Chon Buri, 20000

  • Kalasin Hospital

    Muang, Changwat Kalasin, 46000

  • Khon Kaen Hospital

    Muang, Changwat Khon Kaen

  • Maharaj Nakhon Si Thammarat Hospital

    Muang, Changwat Nakhon Si Thammarat, 80000

  • Nong Khai Hospital

    Muang, Changwat Nong Khai, 43000

  • Pranangklao Hospital

    Muang, Changwat Nonthaburi

  • Pathumthani Hospital

    Muang, Changwat Pathum Thani, 12000

  • Buddhachinaraj Hospital

    Muang, Changwat Phitsanulok

  • Rayong Hospital

    Muang, Changwat Rayong, 21000

  • Trat Hospital

    Muang, Changwat Trat, 23000

  • Chiangrai Prachanukroh Hospital

    Muang, Chiangrai, 57000

  • Mahasarakam Hospital

    Muang, Mahasarakam, 44000

  • Nakhonpathom Hospital

    Muang, Nakhonpathom

  • Samutsakhon Hospital

    Muang, Samutsakhon, 74000

  • Songkhla Hospital

    Muangsongkhla, Changwat Songkhla, 90100

  • Phaholpolphayuhasena Hospital

    Munag, Kanchanaburi, 71000

  • Panasnikom Hospital

    Panasnikom, Changwat Chon Buri, 20140

  • Phan Hospital

    Phan, Changwat Chiang Rai

  • Phayao Provincial Hospital

    Phayao, Changwat Phayao, 56000

  • Vachira Phuket Hospital

    Phuket, 83000

  • Bhumibol Adulyadej Hospital

    Saimai, Bangkok

  • Samutprakarn Hospital

    Samutprakarn, Samutprakarn, 10280

  • Sanpatong Hospital

    Sanpatong, Chiang Mai

  • Ao Udom Hospital

    Si Racha, Changwat Chon Buri, 20230

  • Wiangpapao Hospital

    Wiangpapao, Chiangrai, 57170

Other trials in Thailand

About this study

Official title: Maternal and Infant Peripartum Nevirapine, Versus Infant Only Peripartum Nevirapine, or Maternal Lopinavir/Ritonavir in Addition to Standard Zidovudine Prophylaxis for the Prevention of Perinatal HIV in Thailand.

The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses to the infants, in addition to zidovudine (ZDV) prophylaxis (from 28 weeks' gestation and for one week of ZDV in neonates) for the prevention of mother-to-child transmission of HIV-1.

Read the detailed description

Multicenter, placebo-controlled, double blind, clinical trial where non immunocompromised women receiving the ZDV prophylaxis regimen from 28 weeks gestation, as recommended in Thailand, will be randomized to one of two arms:

Arm 1: NVP-NVP:

  • In women, one NVP 200 mg tablet at onset of labor+;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++

Arm 2: PL-NVP:

  • In women, one placebo tablet at onset of labor++;
  • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours+++

Arm 3: LPV/r:

  • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
  • women in Arm 1 will also receive 7-day ZDV 300mg bid plus 3TC 150mg bid from delivery. ++women in Arm 2 will also receive 7-day (ZDV+3TC) Placebo from delivery. +++If the new born weight less than 2500 g, nevirapine will be administered 2 mg./1 kg (As per Thai Guideline).

All infants will receive ZDV for at least one week. Follow-up of women and infants is carried out on an outpatient basis except for delivery and the first three days after delivery. Mothers and infants are followed-up for 24 months after delivery.

Note: The study was stopped and data unblinded upon DSMB recommendations in September 2010 because of changes in Thai PMTCT guidelines recommending use of HAART in all HIV infected pregnant women regardless of their CD4 count. At the time of unblinding 435 pregnant women had been enrolled and follow-up of these women and their children is continuing.

Being tested
Maternal and infant nevirapine, Maternal placebo and infant nevirapine, Maternal lopinavir+ritonavir, zidovudine
Keywords
Thailand, Developing Countries, Prophylaxis, Mother-to-child transmission, HIV-1, HIV-1 infection, HIV Seronegativity
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maternal and infant nevirapineDrug

    • In women, one NVP 200 mg tablet at onset of labor;
    • In neonates, NVP oral suspension 6 mg in the delivery room immediately

  • Maternal placebo and infant nevirapineDrug

    • In women, one placebo tablet at onset of labor;
    • In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours

    Comparison between Arms 1 and 2 is double-blinded.

  • Maternal lopinavir+ritonavirDrug

    • In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

  • zidovudineDrug

    In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.

Study groups in NCT00409591
Study groupRoleWhat they receive
1Active comparatorNVP-NVP: * In women, one NVP 200 mg tablet at onset of labor; * In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Receives: Drug: Maternal and infant nevirapine; Drug: zidovudine
2ExperimentalPL-NVP: * In women, one placebo tablet at onset of labor; * In neonates, NVP oral suspension 6 mg in the delivery room immediately after birth plus a second dose between 48 and 72 hours
Receives: Drug: Maternal placebo and infant nevirapine; Drug: zidovudine
3ExperimentalLPV/r: * In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
Receives: Drug: Maternal lopinavir+ritonavir; Drug: zidovudine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples

    Measured: At birth, 7-10 days, 1, 2, 4 and 6 months of age

Secondary outcomes (1)

  1. Safety for mothers and children of two NVP doses in neonates with and without maternal single dose NVP at onset of labor or LPV/r from 28 weeks gestation.

    Measured: From randomization during pregnancy until 24 months after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2006 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2010
  4. Study completionJun 2015

Why it stopped: Change in National PMTCT guidelines in Thailand

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00409591
Sponsor's protocol ID
PHPT-5 First Phase
Other IDs
R01HD052461, R01HD056953
Acronym
PHPT-5
Status last verified
Jan 2016
First submitted
8 Dec 2006
Last updated
28 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V; Perinatal HIV Prevention Trial (Thailand) Investigators. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. doi: 10.1056/NEJMoa033500. Epub 2004 Jul 9.

    PubMed 15247338

  • Jourdain G, Ngo-Giang-Huong N, Le Coeur S, Bowonwatanuwong C, Kantipong P, Leechanachai P, Ariyadej S, Leenasirimakul P, Hammer S, Lallemant M; Perinatal HIV Prevention Trial Group. Intrapartum exposure to nevirapine and subsequent maternal responses to nevirapine-based antiretroviral therapy. N Engl J Med. 2004 Jul 15;351(3):229-40. doi: 10.1056/NEJMoa041305. Epub 2004 Jul 9.

    PubMed 15247339

  • Shapiro RL, Thior I, Gilbert PB, Lockman S, Wester C, Smeaton LM, Stevens L, Heymann SJ, Ndung'u T, Gaseitsiwe S, Novitsky V, Makhema J, Lagakos S, Essex M. Maternal single-dose nevirapine versus placebo as part of an antiretroviral strategy to prevent mother-to-child HIV transmission in Botswana. AIDS. 2006 Jun 12;20(9):1281-8. doi: 10.1097/01.aids.0000232236.26630.35.

    PubMed 16816557

  • Cressey TR, Jourdain G, Rawangban B, Varadisai S, Kongpanichkul R, Sabsanong P, Yuthavisuthi P, Chirayus S, Ngo-Giang-Huong N, Voramongkol N, Pattarakulwanich S, Lallemant M; PHPT-5 Team. Pharmacokinetics and virologic response of zidovudine/lopinavir/ritonavir initiated during the third trimester of pregnancy. AIDS. 2010 Sep 10;24(14):2193-200. doi: 10.1097/QAD.0b013e32833ce57d.

    PubMed 20625263

  • Lallemant M, Le Coeur S, Sirirungsi W, Cressey TR, Ngo-Giang-Huong N, Traisathit P, Klinbuayaem V, Sabsanong P, Kanjanavikai P, Jourdain G, Mcintosh K, Koetsawang S; PHPT-5 study investigators. Randomized noninferiority trial of two maternal single-dose nevirapine-sparing regimens to prevent perinatal HIV in Thailand. AIDS. 2015 Nov 28;29(18):2497-507. doi: 10.1097/QAD.0000000000000865.

    PubMed 26372485

  • Sripan P, Le Coeur S, Amzal B, Ingsrisawang L, Traisathit P, Ngo-Giang-Huong N, McIntosh K, Cressey TR, Sangsawang S, Rawangban B, Kanjanavikai P, Treluyer JM, Jourdain G, Lallemant M, Urien S. Modeling of In-Utero and Intra-Partum Transmissions to Evaluate the Efficacy of Interventions for the Prevention of Perinatal HIV. PLoS One. 2015 May 19;10(5):e0126647. doi: 10.1371/journal.pone.0126647. eCollection 2015.

    PubMed 25992639

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maternal and infant nevirapine, Maternal lopinavir+ritonavir and zidovudine in people with HIV Infections and Pregnancy, run by Institut de Recherche pour le Developpement at 43 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 14 inclusion and 9 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: stopped early, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 was stopped early (reason given: Change in National PMTCT guidelines in Thailand). Results are not available in the source record.

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?

Definitive HIV infection in infants as assessed by positive HIV DNA PCR on two peripheral blood samples (time frame: At birth, 7-10 days, 1, 2, 4 and 6 months of age). 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 NCT00409591, which also lists 6 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 28 Jan 2016.

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