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One Month Dual Antiretroviral Prophylaxis to Prevent Resistance Mutations in Mothers Exposed to Single Dose Nevirapine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00142337
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):
Marc Lallemant, Institut de Recherche pour le Developpement

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Zidovudine (ZDV) Drug: Didanosine (ddI) Phase 2

Detailed Description:

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.

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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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Zidovudine (ZDV)
    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.
  • Drug: Didanosine (ddI)
    250 mg ddI-EC (400 mg if body weight >60 kg) once daily, starting at the onset of labor and for one month postpartum

Primary Outcome Measures :
  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 [ Time Frame: Within 4 months postpartum ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00142337

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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
Sponsors and Collaborators
Institut de Recherche pour le Developpement
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Principal Investigator: Marc Lallemant, MD Institut de Recherche pour le Developpement

Publications of Results:
Other Publications:
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Responsible Party: Marc Lallemant, Senior Researcher, Institut de Recherche pour le Developpement 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:
Prevention of mother to child transmission of HIV
Postpartum period

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
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