Nevirapine Plus Zidovudine to Prevent Perinatal HIV in Thailand
NCT ID: NCT00398684
Last Updated: 2008-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1792 participants
INTERVENTIONAL
2001-01-31
2004-06-30
Brief Summary
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Detailed Description
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1. One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth
2. One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth
3. One dose maternal placebo at onset of labor, and one dose of infant placebo 48-72 hours after birth. This was the reference study arm.
Follow-up of women and infants was carried out on an outpatient basis except for delivery and the first three days after delivery.
AMENDMENT
After the first interim analysis, enrollment in Placebo-Placebo arm was terminated on May 2, 2002, according to the recommendation of the Data and Safety Monitoring Board. The target sample size was increased to 660, instead of 510, in each of the two remaining arms (N-N and N-P) to ensure enough power to test for non-inferiority between these arms with a limit of 2.5%.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth (NVP-NVP)
Single dose nevirapine to the mother and to the child
One maternal 200 mg NVP dose at the onset of labor, and one dose of infant NVP (0.6 ml/6mg) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
2
One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth. (NVP-Placebo)
Single dose nevirapine to the mother and placebo to the child
One maternal 200 mg NVP dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
3
One dose maternal placebo at onset of labor, and one dose of infant placebo 48-72 hours after birth. This was the reference study arm. (Placebo-Placebo)
Single dose placebo to the mother and to the child
One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
Interventions
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Single dose nevirapine to the mother and to the child
One maternal 200 mg NVP dose at the onset of labor, and one dose of infant NVP (0.6 ml/6mg) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
Single dose nevirapine to the mother and placebo to the child
One maternal 200 mg NVP dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
Single dose placebo to the mother and to the child
One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]
Eligibility Criteria
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Inclusion Criteria
* were to be provided ZDV Prophylaxis (starting at 28 weeks or as soon as possible thereafter);
* intended to carry the pregnancy to term;
* intended to deliver at and bring their infant to a study site for at least 12 months after delivery; and
* could provide informed consent.
Women are eligible for the study if they:
* met all pre-entry criteria;
* agreed not to breastfeed;
* consented to participate and to be followed for the duration of the study;
* presented the following laboratory values within 14 days prior to randomization:
* hemoglobin \> 8.0 mg/dl
* absolute neutrophil count \> 1000 cells/mm3
* platelets \> 100,000 cells/mm3
* serum creatinine \< 1.5 mg/dl (women with a serum creatinine \> 1.5 mg/dl must have a measured eight-hour urine creatinine clearance \> 70 ml/min)
* SGPT less than 10 times the upper limit of normal NOTE: Women with a Grade 2 or Grade 3 SGPT value (between 2.6 and 10 times the upper limit of normal) were allowed on study; they were monitored monthly until delivery. If at any point their SGPT value rose to a Grade 4 (more than 10 times the upper limit of normal), they should not be dosed with the Study Drug.
Exclusion Criteria
* known hypersensitivity to any benzodiazepine or to NVP;
* receipt of antiretroviral agent other than ZDV;
* receipt of non-allowed concomitant treatment;
* uncontrolled hypertension;
* concurrent participation in another clinical trial;
* women with a CD4 count \<200/µL or history of oral candidiasis if they were not receiving PCP prophylaxis.
FEMALE
No
Sponsors
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Harvard School of Public Health (HSPH)
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
ANRS, Emerging Infectious Diseases
OTHER_GOV
Institut de Recherche pour le Developpement
OTHER_GOV
Principal Investigators
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Marc Lallemant, MD
Role: PRINCIPAL_INVESTIGATOR
Institut de Recherche pour le Developpement
Locations
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Phpt - Ird 174
Chiang Mai, Chiang Mai, Thailand
Countries
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References
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Cressey TR, Jourdain G, Lallemant MJ, Kunkeaw S, Jackson JB, Musoke P, Capparelli E, Mirochnick M. Persistence of nevirapine exposure during the postpartum period after intrapartum single-dose nevirapine in addition to zidovudine prophylaxis for the prevention of mother-to-child transmission of HIV-1. J Acquir Immune Defic Syndr. 2005 Mar 1;38(3):283-8.
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.
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.
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.
Van Dyke RB, Ngo-Giang-Huong N, Shapiro DE, Frenkel L, Britto P, Roongpisuthipong A, Beck IA, Yuthavisuthi P, Prommas S, Puthanakit T, Achalapong J, Chotivanich N, Rasri W, Cressey TR, Maupin R, Mirochnick M, Jourdain G; IMPAACT P1032 Protocol Team. A comparison of 3 regimens to prevent nevirapine resistance mutations in HIV-infected pregnant women receiving a single intrapartum dose of nevirapine. Clin Infect Dis. 2012 Jan 15;54(2):285-93. doi: 10.1093/cid/cir798. Epub 2011 Dec 5.
Related Links
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Program for HIV Prevention and Treatment (PHPT), Thailand
Other Identifiers
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PHPT-2; R01-HD39615; ANRS 1208
Identifier Type: -
Identifier Source: org_study_id