Not Signed In -
Zidovudine Injection |
Azidothymidine Injection; AZT Injection; Compound S; Retrovir Injection |
Clinical Trial: One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine
This study is currently recruiting patients.
Verified by Institut de Recherche pour le Developpement September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| HIV Postpartum Period | Drug: Zidovudine (ZDV) – drug Drug: Didanosine (ddI) - drug | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: 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
Expected Total Enrollment: 244
Study start: December 2004; Expected completion: December 2006
Last follow-up: May 2006; Data entry closure: June 2006
A single nevirapine dose to the mother, with or without a dose to the child, in addition to oral ZDV prophylaxis starting from 28 weeks gestation has been proven to be highly effective in reducing further mother-to-child HIV transmission (PMTCT).
However, post exposure nevirapine resistance mutations are observed in the mother’s viral population. These mutations detectable very early after exposure tend to disappear over time.
Nevertheless, they may be associated with decrease in efficacy of non-nucleoside reverse transcriptase inhibitors (NNRTI) containing regimens subsequently given to the women for their own health.
Therefore, there is a need for research to prevent selection of resistance in the first place or to overcome the resistance in subsequent treatment of the infected mother or infant.
Nevirapine plasma levels above IC50 have been detected in women exposed to a single 200 mg dose of nevirapine in a significant number of women during the third week postpartum.
We hypothesize that giving ZDV+ddI to women exposed to nevirapine for one month as soon as possible after exposure may prevent the selection of nevirapine resistance mutations.
Eligibility
Inclusion Criteria:
- Meet all pre-entry criteria;
- Consent to participate and to be followed for the duration of the study;
- Present the following laboratory values within 14 days prior to inclusion:
- 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).
Exclusion Criteria:
- 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 PCP prophylaxis
- Any other contra-indicated drugs during ZDV+ddI treatment for the mother as well as the child (Are not allowed during the ZDV ddI treatment after delivery such as gancyclovir, isoniazid, linezolid, ethambutol, rifabutin, cidofovir in order to prevent pharmacological interactions or overlapping toxicities)
Location and Contact Information
Gonzague Jourdain, MD +66 53814633 Ext. 0 gonzague@phpt.org
Thailand
Bhumibol Adulyadej Hospital, Bangkok, 10220, Thailand; Recruiting
Napawadee Impoolsup, MD, Principal Investigator
Health Promotion Hospital Regional Center I, Bangkok, 10220, Thailand; Recruiting
Surat Sirinontakan, MD, Principal Investigator
Somdej Pranangchao Sirikit Hospital, Chonburi, 20180, Thailand; Recruiting
Witaya Pornkitprasarn, MD, Principal Investigator
Samutprakarn Hospital, Samutprakarn, 10280, Thailand; Recruiting
Prapan Sabsanong, MD, Principal Investigator
Thailand, Chacheongsao
Chacheongsao Hospital, Muang, Chacheongsao, 24000, Thailand; Recruiting
Annop Kanjanasing, MD, Principal Investigator
Thailand, Chantaburi
Prapokklao Hospital, Muang, Chantaburi, 22000, Thailand; Recruiting
Praparb Yuthavisuthi, MD, Principal Investigator
Thailand, Chiang Mai
Health Promotion Center Region 10, Muang, Chiang Mai, 50100, Thailand; Recruiting
Veerachai Sittipiyasakul, MD, Principal Investigator
Lamphun Hospital, Munag, Chiang Mai, 51000, Thailand; Recruiting
Wanmanee Matanasaravoot, MD, Principal Investigator
Nakornping Hospital, Mae Rim, Chiang Mai, 50180, Thailand; Recruiting
Vorapin Gomuthbutra, MD, Principal Investigator
Thailand, Chiang Rai
Phan Hospital, Phan, Chiang Rai, 57120, Thailand; Recruiting
Sivaporn Jungpichanvanich, MD, Principal Investigator
Mae Sai Hospital, Mae Sai, Chiang Rai, 57130, Thailand; Recruiting
Sura Kunkongkapan, MD, Principal Investigator
Mae Chan Hospital, Mae Chan, Chiang Rai, 57110, Thailand; Recruiting
Sudanee Buranabanjasatean, MD, Principal Investigator
Thailand, Chiangrai
Chiangrai Prachanukroh Hospital, Muang, Chiangrai, 57000, Thailand; Recruiting
Jullapong Achalapong, MD, Principal Investigator
Thailand, Chonburi
Chonburi Hospital, Muang, Chonburi, 20000, Thailand; Recruiting
Nantasak Chotivanich, MD, Principal Investigator
Thailand, Kalasin
Kalasin Hospital, Muang, Kalasin, 46000, Thailand; Recruiting
Bunpode Suwannachat, MD, Principal Investigator
Thailand, Kanjanaburi
Phaholpolphayuhasena Hospital, Munag, Kanjanaburi, 71000, Thailand; Recruiting
Yupa Srivarasat, MD, Principal Investigator
Thailand, Khon Kaen
Srinagarind Hospital, Muang, Khon Kaen, 40002, Thailand; Recruiting
Pope Kosalaraksa, MD, Principal Investigator
Chuanchom Sakondhavat, MD, Principal Investigator
Khon Kaen Hospital, Muang, Khon Kaen, 40000, Thailand; Recruiting
Janyaporn Ratanakosol, MD, Principal Investigator
Regional Health Promotion Centre 6, Khon Kaen, Muang, Khon Kaen, 40000, Thailand; Recruiting
Narong Winiyakul, MD, Principal Investigator
Kranuan Crown Prince Hospital, Kranuan, Khon Kaen, 40170, Thailand; Recruiting
Ruangyot Thongdej, MD, Principal Investigator
Thailand, Lampang
Lampang Hospital, Muang, Lampang, 52000, Thailand; Recruiting
Prateung Liampongsabuddhi, MD, Principal Investigator
Thailand, Nakhonpathom
Nakhonpathom Hospital, Muang, Nakhonpathom, 73000, Thailand; Recruiting
Veeradet Chalermpolprapa, MD, Principal Investigator
Thailand, Nakornratchasrima
Maharaj Nakornratchasrima Hospital, Muang, Nakornratchasrima, 30000, Thailand; Recruiting
Pichit Puernngoluerm, MD, Principal Investigator
Thailand, Nong Kai
Nong Khai Hospital, Muang, Nong Kai, 43000, Thailand; Recruiting
Nusra P. ruttana-Aroongorn, MD, Principal Investigator
Thailand, Nonthaburi
Pranangklao Hospital, Muang, Nonthaburi, 11000, Thailand; Recruiting
Surachai Pipatnakulchai, MD, Principal Investigator
Thailand, Phayao
Chiang Kham Hospital, Chiang Kham, Phayao, 56110, Thailand; Recruiting
Chaiwat Putiyanun, MD, Principal Investigator
Thailand, Pitsanuloke
Buddhachinaraj Hospital, Muang, Pitsanuloke, 65000, Thailand; Recruiting
Suchila Sritippayawan, MD, Principal Investigator
Thailand, Ratchaburi
Ratchaburi Hospital, Muang, Ratchaburi, 70000, Thailand; Recruiting
Thoed Chonladarat, MD, Principal Investigator
Thailand, Rayong
Rayong Hospital, Muang, Rayong, 21000, Thailand; Recruiting
Supawadee Lorenz, MD, Principal Investigator
Thailand, Roi-et
Roi-et Hospital, Muang, Roi-et, 45000, Thailand; Recruiting
Wanchai Atthakorn, MD, Principal Investigator
Thailand, Samutsakorn
Samutsakorn Hospital, Muang, Samutsakorn, 74000, Thailand; Recruiting
Thammanoon Sukhumanant, MD, Principal Investigator
Thailand, Songkla
Hat Yai Hospital, Hat Yai, Songkla, 90110, Thailand; Recruiting
Tapnarong Jarupanich, MD, Principal Investigator
Marc Lallemant, MD, Principal Investigator, Institut de Recherche pour le Developpement
More Information
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. Epub 2004 Jul 9.
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. Epub 2004 Jul 09.
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.
Last Updated: September 1, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00142337
Health Authority: Thailand: Ministry of Public Health
ClinicalTrials.gov processed this record on 2005-09-06
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