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

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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.

City, postcode or hospital

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.

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.

Conditions: HIV Infections, Pregnancy
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 group	Role	What they receive
1	Active comparator	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 Receives: Drug: Maternal and infant nevirapine; Drug: zidovudine
2	Experimental	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 Receives: Drug: Maternal placebo and infant nevirapine; Drug: zidovudine
3	Experimental	LPV/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.

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)

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.

Jul 2008Jun 2015

First posted11 Dec 2006 (estimated)
Study startJul 2008
Primary completionNov 2010
Study completionJun 2015

Why it stopped: Change in National PMTCT guidelines in Thailand

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)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: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00409591
Acronym / sponsor ID: PHPT-5 / PHPT-5 First Phase
Conditions: HIV Infections, Pregnancy
Keywords: Thailand, Developing Countries, Prophylaxis, Mother-to-child transmission, HIV-1, HIV-1 infection, HIV Seronegativity
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Change in National PMTCT guidelines in Thailand
Enrolment: 435 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: Jul 2008
Primary completion: Nov 2010 (actual)
Study completion: Jun 2015 (actual)
First posted: 11 Dec 2006 (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.

Detailed description

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).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: Maternal and infant nevirapine, Drug: zidovudineNVP-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
2	Experimental	Drug: Maternal placebo and infant nevirapine, Drug: zidovudinePL-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
3	Experimental	Drug: Maternal lopinavir+ritonavir, Drug: zidovudineLPV/r: * In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (14 listed)

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;

Key exclusion criteria (9 listed)

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;

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
Maternal and infant nevirapine* In women, one NVP 200 mg tablet at onset of labor; * In neonates, NVP oral suspension 6 mg in the delivery room immediately	Drug	1
Maternal placebo and infant nevirapine* 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.	Drug	2
Maternal lopinavir+ritonavir- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery	Drug	3
zidovudineIn addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.	Drug	1, 2, 3

Primary outcome

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

1 secondary outcome

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.
Time frame: From randomization during pregnancy until 24 months after delivery

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
Background: PubMed 15247338Lallemant 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.
Background: PubMed 15247339Jourdain 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.
Background: PubMed 16816557Shapiro 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.
Results publication: PubMed 20625263Cressey 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.
Results publication: PubMed 26372485Lallemant 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.
Derived from this study: PubMed 25992639Sripan 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.
Program for HIV Prevention and Treatment (Thailand)Link 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

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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; AzTrials last refreshed its copy on 8 Nov 2026.