HIV InfectionsNCT04350554
Pregnancy in Women With HIV Infection
An observational study of HIV Infections and Pregnancy Related, run by Carlos III Health Institute.
Trial summary
Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy. Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections, Pregnancy Related
- What is being tested?
- Pregnancy
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The Cohort of the Spanish AIDS Research Network (CoRIS) is a prospective multicentre cohort of HIV-positive treatment-naïve patients aged >13 years, recruited from 46 centres from 13 Autonomous Regions in the Spanish public healthcare system. Recruitment and follow-up started in 2004 and are still ongoing. From 2004 to the last update in November 2018, 15,509 patients have been included in the cohort. This study will be performed using the update of November 2019, that will be available in June 2020.
Who may be able to join
- HIV-positive women recruited in CoRIS
- Became pregnant from January 2004 to November 2019
- or become pregnant during the year 2020 and agree to participate in a telephone survey
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pregnancy in Women With HIV Infection: a Multicenter Cohort in Spain
Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy.
Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes.
Read more
There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study.
The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020.
Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.
- Conditions
- HIV Infections, Pregnancy Related
- Being tested
- Pregnancy
- Keywords
- HIV, Pregnancy, Adverse pregnancy outcomes
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregnancyOther
To measure and characterize pregnancies and describe the clinical course during pregnancy
PregnancyOther
To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020
| Study group | Role | What they receive |
|---|---|---|
| Retrospective pregnancies | Women recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period. Receives: Other: Pregnancy | |
| Prospective pregnancies | Women recruited in CoRIS from January 2004 to November 2019 who will become pregnant during the year 2020 and who agree to participate in a telephone survey. Receives: Other: Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pregnancies
Measured: From 2004 to 2019
Epidemiological characteristics of women who become pregnant
Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant
Measured: 2004 to 2019
Clinical course during pregnancy
Proportion of women with undetectable viral load at week 36 of pregnancy
Measured: 2004 to 2019
Opportunistic infections during pregnancy
Incidence of opportunistic infections throughout pregnancy
Measured: 2004 to 2019
Persistence of Antiretroviral treatment (ART) during pregnancy
Time from ART initition to treatment change during pregnancy
Measured: 2004 to 2019
Antiretroviral treatment (ART) administered to pregnant women
Distribution of ART regimens administered to women at pregnancy
Measured: 2004 to 2019
Follow-up after pregnancy
Rate of lost-to-follow-up during the first year after pregnancy termination
Measured: 2004 to 2019
Clinical outcomes after pregnancy
Proportion of women with undetectable viral load 6 months after pregnancy termination
Measured: 2004 to 2019
Outcome of the conception
Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies
Measured: 2004 to 2019
Term pregnancies
Proportion of term pregnancies
Measured: 2004 to 2019
Type of delivery
Proportion of vaginal deliveries
Measured: 2004 to 2019
HIV infection of the newborn
Proportion of newborns with HIV infections
Measured: 2004 to 2019
Attitudes towards pregnancy
Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)
Measured: Pregnancies during the year 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos III Health Institute
- Sponsor type
- Other government
- Collaborators
- Red Temática de Investigación Cooperativa en Sida, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Inmaculada Jarrín Vera, Carlos III Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350554
- Sponsor's protocol ID
- RIS_EPICLIN_04_2020
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be made publicly available because they are owned by a third party, the AIDs Research Network (RIS), and because participants agreed that data would only be used for research projects by RIS or those projects approved by its Executive and Scientific Committee. Interested readers may send requests for the data to proyectoscoris@gmail.com. Requests will be assessed by the Executive and Scientific Committee
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy in Women With HIV Infection: a Multicenter Cohort in Spain
- ClinicalTrials.gov ID
- NCT04350554
- Acronym / sponsor ID
- RIS_EPICLIN_04_2020
- Conditions
- HIV Infections, Pregnancy Related
- Keywords
- HIV, Pregnancy, Adverse pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Carlos III Health InstituteOther government
- Collaborators
- Red Temática de Investigación Cooperativa en Sida, Merck Sharp & Dohme LLC
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women living with HIV face multiple challenges regarding pregnancy, encompassing not only their intention to procreate, but also difficulties during the course of pregnancy.
Compared to HIV-negative controls, HIV-infected women have a higher risk of pregnancy complications such as preeclampsia, gestational diabetes, or preterm labor. In addition, the treatment of HIV among pregnant women entails specific difficulties, such as changes in bioavailability of antiretroviral drugs, or the concern about the association of certain antiretrovirals with adverse pregnancy outcomes.
There is very little evidence about pregnancy among women living with HIV in Spain. Very few studies have been published, performed in single centers or in small cohorts with a limited number of patients. The Cohort of the Spanish AIDS Research Network (CoRIS) offers a unique setting to answer questions that are unlikely to be answered by a single study.
The aims of this study are (i) to describe the incidence of pregnancies and their temporal trends from 2004 to 2019, (ii) o describe the clinical and epidemiological characteristics of women who become pregnant, (iii) to assess the diagnostic delay among women diagnosed with HIV infection after becoming pregnant, (iv) to investigate the clinical course during pregnancy and its predictive factors, (v) to describe the antiretroviral treatment administered to pregnant women, (vi) to describe clinical outcomes after pregnancy, (vii) to describe the outcome of the conception in terms of interrupted pregnancies, spontaneous abortions, term pregnancies, type of delivery (vaginal or caesarean section) and HIV infection of the newborn, and (vii) to evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020.
Study population will be women from the cohort of the Spanish AIDS Research Network (CoRIS) who have become pregnant in the period 2004-2010.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective pregnancies | – | Other: PregnancyWomen recruited in CoRIS from January 2004 to November 2019 and who became pregnant during this period. |
| Prospective pregnancies | – | Other: PregnancyWomen recruited in CoRIS from January 2004 to November 2019 who will become pregnant during the year 2020 and who agree to participate in a telephone survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The Cohort of the Spanish AIDS Research Network (CoRIS) is a prospective multicentre cohort of HIV-positive treatment-naïve patients aged >13 years, recruited from 46 centres from 13 Autonomous Regions in the Spanish public healthcare system. Recruitment and follow-up started in 2004 and are still ongoing. From 2004 to the last update in November 2018, 15,509 patients have been included in the cohort. This study will be performed using the update of November 2019, that will be available in June 2020.
Key inclusion criteria (3 listed)
- HIV-positive women recruited in CoRIS
- Became pregnant from January 2004 to November 2019
- or become pregnant during the year 2020 and agree to participate in a telephone survey
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregnancyTo measure and characterize pregnancies and describe the clinical course during pregnancy | Other | Retrospective pregnancies |
| PregnancyTo evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020 | Other | Prospective pregnancies |
Primary outcome
Incidence of pregnancies
Time frame: From 2004 to 2019
Epidemiological characteristics of women who become pregnant
Time frame: 2004 to 2019
Proportion of diagnostic delay among women diagnosed with HIV infection after becoming pregnant
Clinical course during pregnancy
Time frame: 2004 to 2019
Proportion of women with undetectable viral load at week 36 of pregnancy
Opportunistic infections during pregnancy
Time frame: 2004 to 2019
Incidence of opportunistic infections throughout pregnancy
Persistence of Antiretroviral treatment (ART) during pregnancy
Time frame: 2004 to 2019
Time from ART initition to treatment change during pregnancy
Antiretroviral treatment (ART) administered to pregnant women
Time frame: 2004 to 2019
Distribution of ART regimens administered to women at pregnancy
Follow-up after pregnancy
Time frame: 2004 to 2019
Rate of lost-to-follow-up during the first year after pregnancy termination
Clinical outcomes after pregnancy
Time frame: 2004 to 2019
Proportion of women with undetectable viral load 6 months after pregnancy termination
Outcome of the conception
Time frame: 2004 to 2019
Proportion of interrupted pregnancies, spontaneous abortions and term pregnancies
Term pregnancies
Time frame: 2004 to 2019
Proportion of term pregnancies
Type of delivery
Time frame: 2004 to 2019
Proportion of vaginal deliveries
HIV infection of the newborn
Time frame: 2004 to 2019
Proportion of newborns with HIV infections
Attitudes towards pregnancy
Time frame: Pregnancies during the year 2020
Proportion of unintended pregnancies (unplanned or unwanted at the time of conception)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No. Data cannot be made publicly available because they are owned by a third party, the AIDs Research Network (RIS), and because participants agreed that data would only be used for research projects by RIS or those projects approved by its Executive and Scientific Committee. Interested readers may send requests for the data to proyectoscoris@gmail.com. Requests will be assessed by the Executive and Scientific Committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Pregnancy Related, run by Carlos III Health Institute.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inma Jarrin, PhD (0034918222863, ijarrin@isciii.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pregnancies (time frame: From 2004 to 2019). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.