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HIV InfectionPhase 2TEmAANCT00334256

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

A Phase 2 study testing Tenofovir (TDF) and Emtricitabine (FTC) in people with HIV Infection and Pregnancy, run by French National Agency for Research on AIDS and Viral Hepatitis at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
HIV Infection, Pregnancy
What is being tested?
Tenofovir (TDF) and Emtricitabine (FTC)
How many people
72 participants
Where
3 sitesin 3 countries
Study dates
Oct 2006to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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 :
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  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Cambodia1 site

  • Calmette Hospital

    Phnom Penh

Other trials in Cambodia

Côte d’Ivoire1 site

  • Centre de Prise en Charge et de Formation ACONDA

    Abidjan

Other trials in Côte d’Ivoire

South Africa1 site

  • PHRU

    Soweto

Other trials in South Africa

About this 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

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.

Read the 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.

Being tested
Tenofovir (TDF), Emtricitabine (FTC)
Keywords
PMTCT, Resistance, HIV infection, Pregnancy
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir (TDF)Drug

  • Emtricitabine (FTC)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetic parameters of TDF and FTC in the mother and child

    Measured: during labor and first 72 hours of life

Secondary outcomes (5)

  1. Safety of TDF + FTC in pregnant women

    Measured: during labor and 2 months after delivery

  2. Safety of TDF + FTC in children

    Measured: 2 months after birth

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

    Measured: at D2 and W4 postpartum/postnatal

  4. Effect of the antiretroviral combination on maternal viral load

    Measured: D2 and W4 post-partum

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

    Measured: D3, W4, W6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJul 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334256
Sponsor's protocol ID
ANRS 12109 TEmAA
Acronym
TEmAA
Status last verified
Dec 2011
First submitted
6 Jun 2006
Last updated
5 Dec 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19307941

  • 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.

    PubMed 19104016

  • 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.

    PubMed 18987623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tenofovir (TDF) and Emtricitabine (FTC) in people with HIV Infection and Pregnancy, run by French National Agency for Research on AIDS and Viral Hepatitis at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Cambodia, Côte d’Ivoire, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic parameters of TDF and FTC in the mother and child (time frame: during labor and first 72 hours of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334256, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2011.

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