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

This study has been completed.

Sponsor:

Collaborators:

European and Developing Countries Clinical Trials Partnership (EDCTP)

Gilead Sciences

Information provided by (Responsible Party):

French National Agency for Research on AIDS and Viral Hepatitis

ClinicalTrials.gov Identifier:

NCT00334256

First received: June 6, 2006

Last updated: December 2, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 6, 2006

Last Updated Date

December 2, 2011

Start Date ^ICMJE

October 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic parameters of TDF and FTC in the mother and child [ Time Frame: during labor and first 72 hours of life ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Pharmacokinetic parameters of TDF and FTC in the mother and child

Change History

Complete list of historical versions of study NCT00334256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety of TDF + FTC in pregnant women [ Time Frame: during labor and 2 months after delivery ] [ Designated as safety issue: Yes ]
Safety of TDF + FTC in children [ Time Frame: 2 months after birth ] [ Designated as safety issue: Yes ]
Frequency of viral resistance to TDF and FTC in the mothers and in the infected children [ Time Frame: at D2 and W4 postpartum/postnatal ] [ Designated as safety issue: No ]
Effect of the antiretroviral combination on maternal viral load [ Time Frame: D2 and W4 post-partum ] [ Designated as safety issue: No ]
Estimation of the mother-to-child HIV-1 transmission rate (exploratory study) [ Time Frame: D3, W4, W6 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Safety of TDF + FTC in pregnant women
Safety of TDF + FTC in children
Frequency of viral resistance to TDF and FTC in the mothers at D2 and W4 postpartum and in the infected children at D2 and W4 postnatal
Effect of the antiretroviral combination on maternal viral load
Estimation of the mother-to-child HIV-1 transmission rate (exploratory study)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

HIV Infection
Pregnancy

Intervention ^ICMJE

Drug: Tenofovir (TDF)
Drug: Emtricitabine (FTC)

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Cambodia, Côte D'Ivoire, South Africa

Administrative Information

NCT Number ^ICMJE

NCT00334256

Other Study ID Numbers ^ICMJE

ANRS 12109 TEmAA

Has Data Monitoring Committee

Yes

Responsible Party

French National Agency for Research on AIDS and Viral Hepatitis

Study Sponsor ^ICMJE

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators ^ICMJE

European and Developing Countries Clinical Trials Partnership (EDCTP)
Gilead Sciences

Investigators ^ICMJE

Study Chair:	François Dabis, MD, PhD	Université Bordeaux 2
Principal Investigator:	Didier K Ekouevi, MD, PhD	Programme PACCI Abidjan

Information Provided By

French National Agency for Research on AIDS and Viral Hepatitis

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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