Trial | NCT00334256  Report issue

Title

Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
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.
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.
Study Started
Oct 31
2006
Primary Completion
Jul 31
2009
Study Completion
Dec 31
2009
Last Update
Dec 05
2011
Estimate

Drug Tenofovir (TDF)

Drug Emtricitabine (FTC)

Criteria 

Inclusion Criteria:

Women received voluntary counselling and testing and knows her serological status
HIV-1 or HIV-1+2 infection whose serological diagnosis is confirmed by two samples
Aged 18 years or over on the day of the inclusion
Ongoing pregnancy of between 28 and 38 weeks of gestation from the day of the inclusion. This estimate will be based on the date of the last menstruation, or ultrasound scan, or uterine height measurement
Indication for antiretroviral treatment in the Prevention of Mother-To-Child-Transmission (PMTCT), in line with international or national recommendations in force: WHO's clinical stage 1, 2 and CD4≥200/mm3or stage 3 and CD4≥350/mm3 (No indication of antiretroviral treatment)
Haemoglobin over 8 g/dL in the month preceding inclusion
Blood creatinine less than three times the upper limit of normal values
Creatinine clearance > 49 mL/min
Transaminases (ALAT or ASAT) less than five times the upper limit of normal values
Neutrophils ≥750/mm3
No hypersensitivity to emtricitabine, tenofovir, tenofovir disoproxil fumarate, zidovudine, nevirapine or to the excipients
Signed informed-consent form by the woman and, by the father of the child to be born
Planned delivery in a hospital setting and stay for at least 72 hours afterwards
Agreement to take no other medication during the trial without telling the investigator
Naïve to all antiretroviral treatment and to antiretroviral prophylaxis for PMTCT during a previous pregnancy
Permanent residence close enough to the study centre to enable follow-up as stipulated in the protocol

Exclusion Criteria:

Under 18 years of age
Infected by HIV-2 alone
One of the two parents (father) refuses to sign the consent to participate (available only for Abidjan and Phnom Penh) or the mother ( for the Soweto site)
Indication for antiretroviral treatment (stage 4 or CD4 <200/mm3 or stage 3 and CD4 <350/mm3)
Has already taken antiretrovirals, including any exposure to previous treatment or prophylaxis for PMTCT, before inclusion in the study

Use of drugs which can interfere with the study such as :

nephrotoxic drugs amphotericin B, ganciclovir, valganciclovir or cidofovir, foscarnet, aminosides, pentamidine, cisplatin
anticoagulants (heparin)
Regular use of drug or alcohol
Health problem requiring systematic treatment or hospitalization
Severe pregnancy disease (pre-eclampsia) that is life-threatening for the mother, the infant, or for both
Severe vomiting preventing ingestion of tablets
Refuses to give birth at a study site and to stay in hospital for at least 72 hours afterwards
Renal insufficiency defined by blood creatinine more than three times the upper limit of normal values
Creatinine clearance under or equal to 49 mL/min
Hepatic insufficiency defined by transaminases (ALAT or ASAT) more than five times the upper limit of normal values
Neutrophils <750/mm3
Haemoglobin <8 grams/dL in the month preceding inclusion
Hypersensitivity to emtricitabine, tenofovir, tenofovir disoproxil fumarate, zidovudine, nevirapine or to the excipients
No Results Posted