One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine
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ClinicalTrials.gov Identifier: NCT00142337 |
Recruitment Status
:
Completed
First Posted
: September 2, 2005
Last Update Posted
: January 6, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Zidovudine (ZDV) Drug: Didanosine (ddI) | Phase 2 |
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 inhibitor (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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 244 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | February 2009 |
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Drug: Zidovudine (ZDV)
- 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 [ Time Frame: Within 4 months postpartum ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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 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.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142337
Thailand | |
Chacheongsao Hospital | |
Muang, Chacheongsao, Thailand, 24000 | |
Prapokklao Hospital | |
Muang, Chantaburi, Thailand, 22000 | |
Nakornping Hospital | |
Mae Rim, Chiang Mai, Thailand, 50180 | |
Health Promotion Center Region 10 | |
Muang, Chiang Mai, Thailand, 50100 | |
Lamphun Hospital | |
Munag, Chiang Mai, Thailand, 51000 | |
Mae Chan Hospital | |
Mae Chan, Chiang Rai, Thailand, 57110 | |
Mae Sai Hospital | |
Mae Sai, Chiang Rai, Thailand, 57130 | |
Phan Hospital | |
Phan, Chiang Rai, Thailand, 57120 | |
Chiangrai Prachanukroh Hospital | |
Muang, Chiangrai, Thailand, 57000 | |
Chonburi Hospital | |
Muang, Chonburi, Thailand, 20000 | |
Kalasin Hospital | |
Muang, Kalasin, Thailand, 46000 | |
Phaholpolphayuhasena Hospital | |
Munag, Kanjanaburi, Thailand, 71000 | |
Kranuan Crown Prince Hospital | |
Kranuan, Khon Kaen, Thailand, 40170 | |
Khon Kaen Hospital | |
Muang, Khon Kaen, Thailand, 40000 | |
Regional Health Promotion Centre 6, Khon Kaen | |
Muang, Khon Kaen, Thailand, 40000 | |
Srinagarind Hospital | |
Muang, Khon Kaen, Thailand, 40002 | |
Lampang Hospital | |
Muang, Lampang, Thailand, 52000 | |
Nakhonpathom Hospital | |
Muang, Nakhonpathom, Thailand, 73000 | |
Maharaj Nakornratchasrima Hospital | |
Muang, Nakornratchasrima, Thailand, 30000 | |
Nong Khai Hospital | |
Muang, Nong Kai, Thailand, 43000 | |
Pranangklao Hospital | |
Muang, Nonthaburi, Thailand, 11000 | |
Chiang Kham Hospital | |
Chiang Kham, Phayao, Thailand, 56110 | |
Buddhachinaraj Hospital | |
Muang, Pitsanuloke, Thailand, 65000 | |
Ratchaburi Hospital | |
Muang, Ratchaburi, Thailand, 70000 | |
Rayong Hospital | |
Muang, Rayong, Thailand, 21000 | |
Roi-et Hospital | |
Muang, Roi-et, Thailand, 45000 | |
Samutsakorn Hospital | |
Muang, Samutsakorn, Thailand, 74000 | |
Hat Yai Hospital | |
Hat Yai, Songkla, Thailand, 90110 | |
Bhumibol Adulyadej Hospital | |
Bangkok, Thailand, 10220 | |
Health Promotion Hospital Regional Center I | |
Bangkok, Thailand, 10220 | |
Somdej Pranangchao Sirikit Hospital | |
Chonburi, Thailand, 20180 | |
Samutprakarn Hospital | |
Samutprakarn, Thailand, 10280 |
Principal Investigator: | Marc Lallemant, MD | Institut de Recherche pour le Developpement |
Publications of Results:
Other Publications:
Responsible Party: | Marc Lallemant, Senior Researcher, Institut de Recherche pour le Developpement |
ClinicalTrials.gov Identifier: | NCT00142337 History of Changes |
Other Study ID Numbers: |
IRD-UMI 174 PHPT-4 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | January 6, 2012 |
Last Verified: | January 2012 |
Keywords provided by Marc Lallemant, Institut de Recherche pour le Developpement:
zidovudine didanosine Prevention of mother to child transmission of HIV nevirapine |
Thailand Resistance HIV Postpartum period |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Didanosine Nevirapine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |