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Prospective Observational Cohort Study on Mother to Child Transmission HIV1/HIV2 and Prevention (EPF)

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ClinicalTrials.gov Identifier: NCT03235310
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases ( French National Agency for Research on AIDS and Viral Hepatitis )

Brief Summary:
The purpose of this study is to describe over time the rate of mother to child transmission of HIV and its prevention (PMTCT), to identify risk factors for transmission and to evaluate the safety of PMTCT strategies on outcome of pregnancy and in children not infected with HIV

Condition or disease
Mother to Child Transmission of HIV

Detailed Description:

The CO1-EPF prospectively enrolled HIV-infected women who deliver in 25 centers throughout France, except in case of refusal.

Maternal clinical, biological and therapeutic data before and during pregnancy are collected at delivery. The children are examined clinically and biologically at birth, 1, 3, 6, 12 and 24 months. An infant is considered as non infected if two virologic tests are negative beyond the prophylactic treatment or serology is negative after 18 months. An infant is considered as infected if HIV1 is detected by virologic tests on two occasions (polymerase chain reactions, viral culture or p24 antigenemia) and if anti-HIV1 antibodies (ELISA and Western blot) persist after 18 months of age. Follow up is stopped at 24 months for uninfected infants whereas infected infants are enrolled in the CO10 EPF paediatric cohort. No specific recommendation for HIV treatment and obstetrical care are made for women and children included in the cohort, although national guidelines for prevention of MTCT are regularly published and updated. Frozen maternal samples blood and plasma are stored in a centralized laboratory. A research of patients patients lost to follow-up (last visit <24 months) and monitoring is performed regularly in all sites.

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Study Type : Observational
Estimated Enrollment : 18200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: ANRS CO1 EPF Prospective Observational Cohort Study on Mother-to-child Transmission HIV1 and/or HIV2 and Prevention
Study Start Date : July 1997
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS




Primary Outcome Measures :
  1. Efficacy of PMTCT strategies by measuring rate of mother to child transmission of HIV [ Time Frame: At birth, 1 month, 3 months, 6 months, 12 months and 18-24 months ]
    Number of infected children (HIV RNA >50c/mL or Positive serology) reported on the total number of children


Secondary Outcome Measures :
  1. Immuno-virological response during pregnancy [ Time Frame: At inclusion up to childbirth ]
    HIV ARN <50c/mL, CD4 cells count>500 cells/mL

  2. Tolerance and toxicity of different kind of MTCT prophylaxis during pregnancy [ Time Frame: At inclusion up to childbirth ]
    incidence of pathologies during pregnancy (Number of cases of preeclampsia, Number of cases of cholestasis, CDC stage)

  3. Impact of different kind of MTCT prophylaxis on childbirth [ Time Frame: At delivery ]
    Childbirth mode (Number of emergency Caesarean section, Number of planned caesarean section)

  4. Impact of different kind of MTCT prophylaxis during pregnancy on uninfected children [ Time Frame: At childbirth, 1 month, 3 months, 6 months, 12 months and 18-24 months ]
    Clinical abnormalities (occurrence of adverse events)

  5. Risk of mother-to-child transmission of VHC, VHB and CMV co-infections [ Time Frame: At birth, 6 months, 12 months and 18-24 months ]
    Hepatitis B serology positive, Hepatitis C serology positive, presence of CMV in the urine


Biospecimen Retention:   Samples Without DNA
3 mL whole blood 3mL plasma


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inclusion as soon as possible during pregnancy of HIV-women in the largest obstetrical sites (17 in Paris area and 8 elsewhere in mainland France)
Criteria

Inclusion Criteria:

  • pregnant women >= 18 years
  • infected with HIV1 and/or HIV2

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235310


Contacts
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Contact: Josiane Warszawski 01 49 59 53 05 josiane.warszawski@inserm.fr
Contact: Maud BROSSARD 01 49 59 53 13 maud.brossard@inserm.fr

Locations
Show Show 28 study locations
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Investigators
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Principal Investigator: Josiane Warszawski CESP INSERM U1018
Publications of Results:

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Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier: NCT03235310    
Other Study ID Numbers: ANRS-CO1-EPF
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ANRS, Emerging Infectious Diseases ( French National Agency for Research on AIDS and Viral Hepatitis ):
HIV
Pregnancy
Prevention of mother-to-child transmission