Pregnancy Clinical Trial
— TEmAAOfficial 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.
Status | Completed |
Enrollment | 72 |
Est. completion date | December 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Cambodia | Calmette Hospital | Phnom Penh | |
Côte D'Ivoire | Centre de Prise en Charge et de Formation ACONDA | Abidjan | |
South Africa | PHRU | Soweto |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis | European and Developing Countries Clinical Trials Partnership (EDCTP), Gilead Sciences |
Cambodia, Côte D'Ivoire, South Africa,
Hirt D, Urien S, Ekouévi DK, Rey E, Arrivé E, Blanche S, Amani-Bosse C, Nerrienet E, Gray G, Kone M, Leang SK, McIntyre J, Dabis F, Tréluyer JM; ANRS 12109. Population pharmacokinetics of tenofovir in HIV-1-infected pregnant women and their neonates (ANRS — View Citation
Hirt D, Urien S, Rey E, Arrivé E, Ekouévi DK, Coffié P, Leang SK, Lalsab S, Avit D, Nerrienet E, McIntyre J, Blanche S, Dabis F, Tréluyer JM. Population pharmacokinetics of emtricitabine in human immunodeficiency virus type 1-infected pregnant women and t — View Citation
TEmAA ANRS 12109 Study group, Arrivé 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, Ekouévi DK, Dabis F. Tolerance and viral resistance after single-dose nevirapine w — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters of TDF and FTC in the mother and child | during labor and first 72 hours of life | No | |
Secondary | Safety of TDF + FTC in pregnant women | during labor and 2 months after delivery | Yes | |
Secondary | Safety of TDF + FTC in children | 2 months after birth | Yes | |
Secondary | Frequency of viral resistance to TDF and FTC in the mothers and in the infected children | at D2 and W4 postpartum/postnatal | No | |
Secondary | Effect of the antiretroviral combination on maternal viral load | D2 and W4 post-partum | No | |
Secondary | Estimation of the mother-to-child HIV-1 transmission rate (exploratory study) | D3, W4, W6 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
Enrolling by invitation |
NCT05415371 -
Persistent Poverty Counties Pregnant Women With Medicaid
|
N/A | |
Completed |
NCT04548102 -
Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman
|
N/A | |
Completed |
NCT03218956 -
Protein Requirement During Lactation
|
N/A | |
Completed |
NCT02191605 -
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
|
N/A | |
Completed |
NCT02223637 -
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
|
||
Recruiting |
NCT06049953 -
Maternal And Infant Antipsychotic Study
|
||
Completed |
NCT02577536 -
PregSource: Crowdsourcing to Understand Pregnancy
|
||
Not yet recruiting |
NCT06336434 -
CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05412238 -
Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months
|
N/A | |
Not yet recruiting |
NCT04786587 -
Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
|
||
Not yet recruiting |
NCT05028387 -
Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
|
||
Completed |
NCT02783170 -
Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women
|
Phase 4 | |
Completed |
NCT02683005 -
Study of Hepatitis C Treatment During Pregnancy
|
Phase 1 | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Recruiting |
NCT02619188 -
Nutritional Markers in Normal and Hyperemesis Pregnancies
|
N/A | |
Recruiting |
NCT02564250 -
Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women
|
N/A | |
Terminated |
NCT02546193 -
Outpatient Foley Catheter Compared to Usual Inpatient Care for Labor Induction
|
N/A |