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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborators: European and Developing Countries Clinical Trials Partnership (EDCTP); Gilead Sciences
• Treatments: Emtricitabine; Tenofovir

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