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Sponsors and Collaborators: |
French National Agency for Research on AIDS and Viral Hepatitis European Developping Countries Trial Partnership Gilead Sciences |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00334256 |
To study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate and emtricitabine in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.
Condition | Intervention | Phase |
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HIV Infection Pregnancy |
Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | Phase II Trial, Multicentre, Opened Label Evaluating the Pharmacokinetics and the Safety and Toxicity of the Tenofovir-Emtricitabine Combination in Pregnant Women and Infants in Africa and Asia |
Estimated Enrollment: | 72 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Single-dose nevirapine (sdNVP) is the option of choice for the prevention of mother-to-child transmission (PMTCT) of HIV-1 in countries with limited resources. However, the use of sdNVP results in resistance mutations with an estimated frequency at of least 15 to 70% in women at W4-W6 postpartum. These mutations could compromise the success of subsequent treatments of mother and child with antiretroviral combinations that include NVP. Pre-clinical and clinical studies suggest that a combination of TDF and FTC, drugs with interesting pharmacokinetic properties that may be a useful alternative or complement to sdNVP.
The objectives are to study the pharmacokinetic properties, safety and viral resistance pattern of the combination of tenofovir disoproxil fumarate {TDF, 600 mg} and emtricitabine {FTC, 400 mg}) in HIV-1-infected pregnant women and their newborns, with a view to prevention of mother-to-child transmission (PMTCT) of HIV-1 in Africa and Asia.
Phase II trial, multicentre, open-label will be conducted in two steps with 30 mother-infant pairs per step and with a balanced allocation in Abidjan (Côte d'Ivoire), Soweto (South Africa) and Phnom Penh (Cambodia):
Step 1: administration of TDF/FTC to the mother; Step 2: administration of TDF/FTC to the mother and the newborn.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of drugs which can interfere with the study such as :
Contact: Elise Arrive | +33 5 57 57 48 10 | Elise.Arrive@isped.u-bordeaux2.fr |
Côte D'Ivoire | |
Centre de Prise en Charge et de Formation ACONDA | Recruiting |
Abidjan, Côte D'Ivoire | |
Contact: Didier K Ekouevi, MD, PhD ekouevi@aviso.ci | |
Principal Investigator: Didier K Ekouevi, MD, PhD | |
Cambodia | |
Calmette Hospital | Recruiting |
Phnom Penh, Cambodia | |
Contact: Eric Nerrienet, PhD enerrienet@pasteur-kh.org | |
Principal Investigator: Sim Kruy, MD | |
South Africa | |
PHRU | Recruiting |
Soweto, South Africa | |
Contact: Sarita Lalsab 0825765952 lalsabs@hivsa.com | |
Principal Investigator: James McIntyre, MD, PhD |
Study Chair: | François Dabis, MD, PhD | Université Bordeaux 2 |
Principal Investigator: | Didier K Ekouevi, MD, PhD | Programme PACCI Abidjan |
Responsible Party: | ANRS ( Director ) |
Study ID Numbers: | ANRS 12109 TEmAA |
Study First Received: | June 6, 2006 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00334256 |
Health Authority: | Cote d'Ivoire: Ministry of AIDS |
PMTCT Resistance HIV infection Pregnancy |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
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 |