Tenofovir/Emtricitabine for PMTCT in Africa and Asia (ANRS 12109 TEmAA)
This study has been completed.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Pregnancy |
Drug: Tenofovir (TDF) Drug: Emtricitabine (FTC) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 72 |
| Study Start Date: | October 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334256
Locations
| Cambodia | |
| Calmette Hospital | |
| Phnom Penh, Cambodia | |
| Côte D'Ivoire | |
| Centre de Prise en Charge et de Formation ACONDA | |
| Abidjan, Côte D'Ivoire | |
| South Africa | |
| PHRU | |
| Soweto, South Africa | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
European and Developing Countries Clinical Trials Partnership (EDCTP)
Gilead Sciences
Investigators
| Study Chair: | François Dabis, MD, PhD | Université Bordeaux 2 |
| Principal Investigator: | Didier K Ekouevi, MD, PhD | Programme PACCI Abidjan |
More Information
Additional Information:
Publications:
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT00334256 History of Changes |
| Other Study ID Numbers: | ANRS 12109 TEmAA |
| Study First Received: | June 6, 2006 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Cote d'Ivoire: Ministry of AIDS |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
PMTCT Resistance HIV infection Pregnancy |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Tenofovir |
Tenofovir disoproxil Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on October 16, 2012
