NCT00398684

Brief Summary

The purpose of this study was to assess the efficacy of a single dose of the drug nevirapine (NVP) given to pregnant women at onset of labor and to their infant 48-72 hours after birth in addition to standard oral zidovudine (ZDV or AZT) prophylaxis for the prevention of mother-to-child transmission of HIV-1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,792

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Jan 2001

Typical duration for phase_3 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

May 7, 2008

Status Verified

May 1, 2008

First QC Date

November 13, 2006

Last Update Submit

May 2, 2008

Conditions

HIV InfectionsPregnancy

Keywords

ThailandDeveloping countriesprophylaxismother to child transmissionHIV-1HIV-1 infectionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Tolerance of nevirapine, in particular rashes.

Study Arms (3)

1

EXPERIMENTAL

One dose maternal NVP treatment at onset of labor, and one dose of infant NVP treatment 48-72 hours after birth (NVP-NVP)

Drug: Single dose nevirapine to the mother and to the child

2

EXPERIMENTAL

One dose maternal NVP treatment at onset of labor, and one dose of infant placebo 48-72 hours after birth. (NVP-Placebo)

Drug: Single dose nevirapine to the mother and placebo to the child

3

PLACEBO COMPARATOR

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)

Drug: Single dose placebo to the mother and to the child

Interventions

Single dose nevirapine to the mother and to the childDRUG

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. \[Infants less than 2,500g received only 0.2mL/kg\]

1
Single dose nevirapine to the mother and placebo to the childDRUG

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. \[Infants less than 2,500g received only 0.2mL/kg\]

2
Single dose placebo to the mother and to the childDRUG

One maternal placebo dose at the onset of labor, and one dose of infant placebo (0.6 ml) between 48-72 hours after birth. \[Infants less than 2,500g received only 0.2mL/kg\]

3

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • evidence of pre-existing fetal anomalies incompatible with life;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phpt - Ird 174

Chiang Mai, Chiang Mai, 50200, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 15735445BACKGROUND

  • 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.

    PMID: 15247339BACKGROUND

  • 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.

    PMID: 15247338RESULT

  • 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. Erratum In: PLoS One. 2015 Jun 26;10(6):e0130917. doi: 10.1371/journal.pone.0130917. PLoS One. 2015 Aug 28;10(8):e0137368. doi: 10.1371/journal.pone.0137368.

    PMID: 25992639DERIVED

  • 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.

    PMID: 22144539DERIVED

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Marc Lallemant, MD

    Institut de Recherche pour le Developpement

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Study Start

January 1, 2001

Study Completion

June 1, 2004

Last Updated

May 7, 2008

Record last verified: 2008-05

Locations

TH(1)