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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.
 
ClinicalTrials.gov Identifier: NCT00142337
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 6, 2012
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00142337


Locations
Show Show 32 study locations
Sponsors and Collaborators
Institut de Recherche pour le Developpement
Investigators
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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
ClinicalTrials.gov Identifier: NCT00142337    
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:
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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
Zidovudine
Didanosine
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