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

January 4, 2012 updated by: Marc Lallemant, Institut de Recherche pour le Developpement

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10220
        • Health Promotion Hospital Regional Center I
      • Bangkok, Thailand, 10220
        • Bhumibol Adulyadej Hospital
      • Chonburi, Thailand, 20180
        • Somdej Pranangchao Sirikit Hospital
      • Samutprakarn, Thailand, 10280
        • Samutprakarn Hospital
    • Chacheongsao
      • Muang, Chacheongsao, Thailand, 24000
        • Chacheongsao Hospital
    • Chantaburi
      • Muang, Chantaburi, Thailand, 22000
        • Prapokklao Hospital
    • Chiang Mai
      • Mae Rim, Chiang Mai, Thailand, 50180
        • Nakornping Hospital
      • Muang, Chiang Mai, Thailand, 50100
        • Health Promotion Center Region 10
      • Munag, Chiang Mai, Thailand, 51000
        • Lamphun Hospital
    • Chiang Rai
      • Mae Chan, Chiang Rai, Thailand, 57110
        • Mae Chan Hospital
      • Mae Sai, Chiang Rai, Thailand, 57130
        • Mae Sai Hospital
      • Phan, Chiang Rai, Thailand, 57120
        • Phan Hospital
    • Chiangrai
      • Muang, Chiangrai, Thailand, 57000
        • Chiangrai Prachanukroh Hospital
    • Chonburi
      • Muang, Chonburi, Thailand, 20000
        • Chonburi Hospital
    • Kalasin
      • Muang, Kalasin, Thailand, 46000
        • Kalasin Hospital
    • Kanjanaburi
      • Munag, Kanjanaburi, Thailand, 71000
        • Phaholpolphayuhasena Hospital
    • Khon Kaen
      • Kranuan, Khon Kaen, Thailand, 40170
        • Kranuan Crown Prince Hospital
      • Muang, Khon Kaen, Thailand, 40002
        • Srinagarind Hospital
      • Muang, Khon Kaen, Thailand, 40000
        • Khon Kaen Hospital
      • Muang, Khon Kaen, Thailand, 40000
        • Regional Health Promotion Centre 6, Khon Kaen
    • Lampang
      • Muang, Lampang, Thailand, 52000
        • Lampang Hospital
    • Nakhonpathom
      • Muang, Nakhonpathom, Thailand, 73000
        • Nakhonpathom Hospital
    • Nakornratchasrima
      • Muang, Nakornratchasrima, Thailand, 30000
        • Maharaj Nakornratchasrima Hospital
    • Nong Kai
      • Muang, Nong Kai, Thailand, 43000
        • Nong Khai Hospital
    • Nonthaburi
      • Muang, Nonthaburi, Thailand, 11000
        • Pranangklao Hospital
    • Phayao
      • Chiang Kham, Phayao, Thailand, 56110
        • Chiang Kham Hospital
    • Pitsanuloke
      • Muang, Pitsanuloke, Thailand, 65000
        • Buddhachinaraj Hospital
    • Ratchaburi
      • Muang, Ratchaburi, Thailand, 70000
        • Ratchaburi Hospital
    • Rayong
      • Muang, Rayong, Thailand, 21000
        • Rayong Hospital
    • Roi-et
      • Muang, Roi-et, Thailand, 45000
        • Roi-et Hospital
    • Samutsakorn
      • Muang, Samutsakorn, Thailand, 74000
        • Samutsakorn Hospital
    • Songkla
      • Hat Yai, Songkla, Thailand, 90110
        • Hat Yai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 4 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Recherche pour le Developpement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (ESTIMATE)

September 2, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRD-UMI 174 PHPT-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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