One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine
A Phase 2, One Arm, Open Label, Feasibility Study Assessing One Month Zidovudine/Didanosine Postpartum Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine to Prevent Mother to Child Transmission of HIV
1 other identifier
interventional
244
1 country
32
Brief Summary
The purpose of this study is to determine whether providing zidovudine (ZDV) and didanosine (ddI) during labor and for one month postpartum can reduce the selection of nevirapine (NVP) resistance mutations postpartum in women who received a single dose of nevirapine during labor and standard ZDV prophylaxis for the prevention of mother to child transmission of HIV.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
Started Dec 2004
Typical duration for phase_2 hiv-infections
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJanuary 6, 2012
January 1, 2012
1.4 years
September 1, 2005
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with viral NNRTI mutations detectable during the 4 month follow-up compared with the incidence observed in the PHPT-2 clinical trial, who received the same antiretroviral prophylaxis but no post-partum regimen
Within 4 months postpartum
Interventions
Zidovudine 300 mg, twice daily, for one month postpartum. Note: after July 03, 2005, all women received 200 mg, twice daily, for the same duration.
250 mg ddI-EC (400 mg if body weight \>60 kg) once daily, starting at the onset of labor and for one month postpartum
Eligibility Criteria
You may qualify if:
- Meet all pre-entry criteria;
- Consent to participate and to be followed for the duration of the study;
- 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
- Amylase less than 150/L IU (this upper limit may change slightly depending on the normal range at the hospital laboratory).
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 or contraindication to ddI
- Concurrent participation in another clinical trial;
- Women with a CD4 count \<200/µL or history of oral candidiasis if they are not receiving pneumocystis carinii pneumonia (PCP) prophylaxis
- Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Contra-indicated drugs such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir are not allowed during the ZDV ddI treatment after delivery in order to prevent pharmacological interactions or overlapping toxicities.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Bhumibol Adulyadej Hospital
Bangkok, Bangkok, 10220, Thailand
Health Promotion Hospital Regional Center I
Bangkok, Bangkok, 10220, Thailand
Chacheongsao Hospital
Muang, Chacheongsao, 24000, Thailand
Prapokklao Hospital
Muang, Changwat Chanthaburi, 22000, Thailand
Mae Chan Hospital
Mae Chan, Changwat Chiang Rai, 57110, Thailand
Mae Sai Hospital
Mae Sai, Changwat Chiang Rai, 57130, Thailand
Phan Hospital
Phan, Changwat Chiang Rai, 57120, Thailand
Somdej Pranangchao Sirikit Hospital
Chon Buri, Changwat Chon Buri, 20180, Thailand
Chonburi Hospital
Muang, Changwat Chon Buri, 20000, Thailand
Kalasin Hospital
Muang, Changwat Kalasin, 46000, Thailand
Kranuan Crown Prince Hospital
Kranuan, Changwat Khon Kaen, 40170, Thailand
Khon Kaen Hospital
Muang, Changwat Khon Kaen, 40000, Thailand
Regional Health Promotion Centre 6, Khon Kaen
Muang, Changwat Khon Kaen, 40000, Thailand
Srinagarind Hospital
Muang, Changwat Khon Kaen, 40002, Thailand
Lampang Hospital
Muang, Changwat Lampang, 52000, Thailand
Nong Khai Hospital
Muang, Changwat Nong Khai, 43000, Thailand
Pranangklao Hospital
Muang, Changwat Nonthaburi, 11000, Thailand
Chiang Kham Hospital
Chiang Kham, Changwat Phayao, 56110, Thailand
Buddhachinaraj Hospital
Muang, Changwat Phitsanulok, 65000, Thailand
Ratchaburi Hospital
Muang, Changwat Ratchaburi, 70000, Thailand
Rayong Hospital
Muang, Changwat Rayong, 21000, Thailand
Roi-et Hospital
Muang, Changwat Roi Et, 45000, Thailand
Hat Yai Hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Nakornping Hospital
Mae Rim, Chiang Mai, 50180, Thailand
Health Promotion Center Region 10
Muang, Chiang Mai, 50100, Thailand
Lamphun Hospital
Munag, Chiang Mai, 51000, Thailand
Chiangrai Prachanukroh Hospital
Muang, Chiangrai, 57000, Thailand
Phaholpolphayuhasena Hospital
Munag, Kanchanaburi, 71000, Thailand
Nakhonpathom Hospital
Muang, Nakhonpathom, 73000, Thailand
Maharaj Nakornratchasrima Hospital
Muang, Nakornratchasrima, 30000, Thailand
Samutprakarn Hospital
Samutprakarn, Samutprakarn, 10280, Thailand
Samutsakorn Hospital
Muang, Samutsakorn, 74000, Thailand
Related Publications (4)
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: 15247338BACKGROUNDJourdain 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: 15247339BACKGROUNDCressey 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: 15735445BACKGROUNDLallemant M, Ngo-Giang-Huong N, Jourdain G, Traisaithit P, Cressey TR, Collins IJ, Jarupanich T, Sukhumanant T, Achalapong J, Sabsanong P, Chotivanich N, Winiyakul N, Ariyadej S, Kanjanasing A, Ratanakosol J, Hemvuttiphan J, Kengsakul K, Wannapira W, Sittipiyasakul V, Pornkitprasarn W, Liampongsabuddhi P, McIntosh K, Van Dyke RB, Frenkel LM, Koetsawang S, Le Coeur S, Kanchana S; PHPT-4 Study Team. Efficacy and safety of 1-month postpartum zidovudine-didanosine to prevent HIV-resistance mutations after intrapartum single-dose nevirapine. Clin Infect Dis. 2010 Mar 15;50(6):898-908. doi: 10.1086/650745.
PMID: 20158398RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Lallemant, MD
Institut de Recherche pour le Developpement
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 2, 2005
Study Start
December 1, 2004
Primary Completion
May 1, 2006
Study Completion
February 1, 2009
Last Updated
January 6, 2012
Record last verified: 2012-01