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Sponsored by: |
Institut de Recherche pour le Developpement |
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Information provided by: | Institut de Recherche pour le Developpement |
ClinicalTrials.gov Identifier: | NCT00142337 |
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 | Intervention | Phase |
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HIV Infections |
Drug: Zidovudine (ZDV) Drug: Didanosine (ddI) |
Phase II |
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 |
Enrollment: | 244 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Present the following laboratory values within 14 days prior to inclusion:
Exclusion Criteria:
Principal Investigator: | Marc Lallemant, MD | Institut de Recherche pour le Developpement |
Responsible Party: | Institut de Recherche pour le Developpement ( Michel Tibayrenc ) |
Study ID Numbers: | IRD-UMI 174 PHPT-4 |
Study First Received: | September 1, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00142337 |
Health Authority: | Thailand: Ministry of Public Health |
zidovudine didanosine Prevention of mother to child transmission of HIV nevirapine |
Thailand Resistance HIV Postpartum period |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral Didanosine HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Zidovudine Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |