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 (PHPT-5)
This study is ongoing, but not recruiting participants.
Sponsor:
Institut de Recherche pour le Developpement
Collaborators:
Harvard School of Public Health
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement
ClinicalTrials.gov Identifier:
NCT00409591
First received: December 8, 2006
Last updated: February 10, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Pregnancy |
Drug: Maternal and infant nevirapine Drug: Maternal placebo and infant nevirapine Drug: Maternal lopinavir+ritonavir Drug: zidovudine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by Institut de Recherche pour le Developpement:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2097 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | January 2014 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
NVP-NVP:
|
Drug: Maternal and infant nevirapine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
|
|
Experimental: 2
PL-NVP:
|
Drug: Maternal placebo and infant nevirapine
Comparison between Arms 1 and 2 is double-blinded. In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
|
|
Experimental: 3
LPV/r:
|
Drug: Maternal lopinavir+ritonavir
- In women, LPV/r 400/100 mg bid from 28 weeks' gestation until delivery
Drug: zidovudine
In addition, all women and infants in the 3 arms will receive standard ZDV prophylaxis, as per Thai and WHO guidelines.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Pre-Entry Criteria
- Evidence of HIV infection (documented by two HIV antibody tests on two different dates)
- Intend to be followed at a study site for the duration of the study
- At least 18 years old
- Written informed consent.
Inclusion Criteria:
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)
- 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).
Exclusion criteria:
- 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;
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409591
Locations
| Thailand | |
| Nopparat Rajathanee Hospital | |
| Kannayao, Bangkok, Thailand, 10230 | |
| Bhumibol Adulyadej Hospital | |
| Saimai, Bangkok, Thailand | |
| Chachoengsao Hospital | |
| Muang, Chachoengsao, Thailand, 24000 | |
| Prapokklao Hospital | |
| Muang, Chantaburi, Thailand, 22000 | |
| Nakornping Hospital | |
| Mae Rim, Chiang Mai, Thailand, 50180 | |
| Sanpatong Hospital | |
| Sanpatong, Chiang Mai, Thailand | |
| Mae Chan Hospital | |
| Mae Chan, Chiang Rai, Thailand | |
| Mae Sai Hospital | |
| Mae Sai, Chiang Rai, Thailand | |
| Phan Hospital | |
| Phan, Chiang Rai, Thailand | |
| Chiang Saen Hospital | |
| Chiang Saen, Chiangrai, Thailand, 57150 | |
| Chiangrai Prachanukroh Hospital | |
| Muang, Chiangrai, Thailand, 57000 | |
| Wiangpapao Hospital | |
| Wiangpapao, Chiangrai, Thailand, 57170 | |
| Banglamung Hospital | |
| Banglamung, Chonburi, Thailand, 20150 | |
| Chonburi Hospital | |
| Muang, Chonburi, Thailand, 20000 | |
| Panasnikom Hospital | |
| Panasnikom, Chonburi, Thailand, 20140 | |
| Ao Udom Hospital | |
| Sri Racha, Chonburi, Thailand, 20230 | |
| Kalasin Hospital | |
| Muang, Kalasin, Thailand, 46000 | |
| Phaholpolphayuhasena Hospital | |
| Munag, Kanjanaburi, Thailand, 71000 | |
| Khon Kaen Hospital | |
| Muang, Khon Kaen, Thailand | |
| Lampang Hospital | |
| Muang, Lampang, Lampang, Thailand, 52000 | |
| Mahasarakam Hospital | |
| Muang, Mahasarakam, Thailand, 44000 | |
| Maharaj Nakhon Si Thammarat Hospital | |
| Muang, Nakhon Si Thammarat, Thailand, 80000 | |
| Nakhonpathom Hospital | |
| Muang, Nakhonpathom, Thailand | |
| Nong Khai Hospital | |
| Muang, Nong Kai, Thailand, 43000 | |
| Pranangklao Hospital | |
| Muang, Nonthaburi, Thailand | |
| Pathumthani Hospital | |
| Muang, Pathumthani, Thailand, 12000 | |
| Chiang Kham Hospital | |
| Chiang Kham, Phayao, Thailand, 56110 | |
| Buddhachinaraj Hospital | |
| Muang, Pitsanulok, Thailand | |
| Rayong Hospital | |
| Muang, Rayong, Thailand, 21000 | |
| Samutsakhon Hospital | |
| Muang, Samutsakhon, Thailand, 74000 | |
| Songkhla Hospital | |
| Muangsongkhla, Songkhla, Thailand, 90100 | |
| Hat Yai Hospital | |
| Hat Yai, Songkla, Thailand, 90110 | |
| Trat Hospital | |
| Muang, Trat, Thailand, 23000 | |
| Health Promotion Hospital Regional Center I | |
| Bangkok, Thailand, 10220 | |
| Health Promotion Center Region 10, | |
| Chiang Mai, Thailand, 50100 | |
| Fang Hospital | |
| Chiang Mai, Thailand, 50110 | |
| Chomthong Hospital | |
| Chiang Mai, Thailand, 50160 | |
| Somdej Pranangchao Sirikit Hospital | |
| Chonburi, Thailand, 20180 | |
| Regional Health Promotion Centre 6, | |
| Khon Kaen, Thailand, 40000 | |
| Lamphun Hospital | |
| Lamphun, Thailand, 51000 | |
| Phayao Provincial Hospital | |
| Phayao, Thailand, 56000 | |
| Vachira Phuket Hospital | |
| Phuket, Thailand, 83000 | |
| Samutprakarn Hospital | |
| Samutprakarn, Thailand, 10280 | |
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Harvard School of Public Health
Investigators
| Principal Investigator: | Marc Lallemant, MD | Institut de Recherche pour le Developpment |
More Information
Additional Information:
Publications:
| Responsible Party: | Marc Lallemant, Senior Researcher, Institut de Recherche pour le Developpement |
| ClinicalTrials.gov Identifier: | NCT00409591 History of Changes |
| Other Study ID Numbers: | PHPT-5 First Phase, R01HD052461, R01HD056953 |
| Study First Received: | December 8, 2006 |
| Last Updated: | February 10, 2013 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by Institut de Recherche pour le Developpement:
|
Thailand Developing Countries Prophylaxis Mother-to-child transmission |
HIV-1 HIV-1 infection HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Zidovudine Nevirapine Ritonavir |
Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents HIV Protease Inhibitors Protease Inhibitors |
ClinicalTrials.gov processed this record on March 14, 2013
