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

NCT00334256 | Completed Phase 2 DMC

• 1 other identifier: ANRS 12109 TEmAA
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 3

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.

Conditions

HIV Infection; Pregnancy

Keywords

PMTCT; Resistance; HIV infection; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters of TDF and FTC in the mother and child

  during labor and first 72 hours of life

Secondary Outcomes (5)

• Safety of TDF + FTC in pregnant women

  during labor and 2 months after delivery

• Safety of TDF + FTC in children

  2 months after birth

• Frequency of viral resistance to TDF and FTC in the mothers and in the infected children

  at D2 and W4 postpartum/postnatal

• Effect of the antiretroviral combination on maternal viral load

  D2 and W4 post-partum

• Estimation of the mother-to-child HIV-1 transmission rate (exploratory study)

  D3, W4, W6

Interventions

Tenofovir (TDF) DRUG

Emtricitabine (FTC) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Gilead Sciences: collaborator

Study Sites (3)

Calmette Hospital

Phnom Penh, Cambodia

Location

Centre de Prise en Charge et de Formation ACONDA

Abidjan, Côte d’Ivoire

Location

PHRU

Soweto, South Africa

Location

Related Publications (3)

• TEmAA ANRS 12109 Study group; Arrive E, Chaix ML, Nerrienet E, Blanche S, Rouzioux C, Coffie PA, Kruy Leang S, McIntyre J, Avit D, Srey VH, Gray G, N'Dri-Yoman T, Diallo A, Ekouevi DK, Dabis F. Tolerance and viral resistance after single-dose nevirapine with tenofovir and emtricitabine to prevent vertical transmission of HIV-1. AIDS. 2009 Apr 27;23(7):825-33. doi: 10.1097/QAD.0b013e32832949d5.

  PMID: 19307941 RESULT

• Hirt D, Urien S, Rey E, Arrive E, Ekouevi DK, Coffie P, Leang SK, Lalsab S, Avit D, Nerrienet E, McIntyre J, Blanche S, Dabis F, Treluyer JM. Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Antimicrob Agents Chemother. 2009 Mar;53(3):1067-73. doi: 10.1128/AAC.00860-08. Epub 2008 Dec 22.

  PMID: 19104016 RESULT

• Hirt D, Urien S, Ekouevi DK, Rey E, Arrive E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Treluyer JM; ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS 12109). Clin Pharmacol Ther. 2009 Feb;85(2):182-9. doi: 10.1038/clpt.2008.201. Epub 2008 Nov 5.

  PMID: 18987623 RESULT

Related Links

• Sponsor web page
• Related Info

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir; Emtricitabine; Racivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• François Dabis, MD, PhD

  Université Bordeaux 2

  STUDY CHAIR

• Didier K Ekouevi, MD, PhD

  Programme PACCI Abidjan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 5, 2011

Record last verified: 2011-12

Locations

CA (1); CÔ (1); ZA (1)