HIV InfectionNCT01865786
A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication
An observational study of HIV Infection, run by Gilead Sciences at 1 site in United States.
Trial summary
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infection
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2013to 13 Mar 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals. All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.
Who may be able to join
- Pregnant women
- Part of the prospective arm of the APR Target Group Inclusion Criteria
- HIV-1 Negative
- Choosing to remain on FTC/TDF for PrEP during pregnancy or,
- Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
- HIV-1 Positive
- On antiretroviral therapy
Who cannot join
- This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Antiretroviral Pregnancy Registry
Wilmington, North Carolina, 28405
About this study
Official title: A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).
Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.
- Conditions
- HIV Infection
- Keywords
- FTC/TDF, Truvada, PrEP, Antiretroviral Pregnancy Registry
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FTC/TDF for PrEP | The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy. | |
| ARV population | The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected. This is a propensity score matched retrospective cohort selected from the prospective arm of the APR. This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
Measured: Year 1
Secondary outcomes (1)
Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
Measured: Years 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study start1 Jan 2013
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865786
- Sponsor's protocol ID
- GS-US-276-0101
- Status last verified
- Mar 2018
- First submitted
- 22 May 2013
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of Pregnancy Outcomes Among Women Exposed to Truvada for PrEP Indication Nested in the Antiretroviral Pregnancy Registry
- ClinicalTrials.gov ID
- NCT01865786
- Acronym / sponsor ID
- GS-US-276-0101
- Conditions
- HIV Infection
- Keywords
- FTC/TDF, Truvada, PrEP, Antiretroviral Pregnancy Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 31 May 2013 (estimated)
- 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.
This is a prospective, observational study to describe pregnancy outcomes among HIV-1 uninfected pregnant women who are taking emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) (Truvada®) for a pre-exposure prophylaxis (PrEP) indication nested in the Antiretroviral Pregnancy Registry (APR).
Information on subjects is provided to the APR prospectively (prior to the outcome of the pregnancy being known) through their healthcare provider, with follow-up obtained from the healthcare provider following determination of the pregnancy outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTC/TDF for PrEP | – | –The study has one target prospective cohort defined as HIV-1 negative women who had been prescribed FTC/TDF for pre-exposure prophylaxis (PrEP); with two strata: a) those who continue to take FTC/TDF for PrEP during their pregnancy, and b) those who decide to stop FTC/TDF for PrEP during pregnancy. |
| ARV population | – | –The study has one comparison cohort defined as HIV-positive women who were on any antiretroviral (ARV) medication at the time the pregnancy was detected. This is a propensity score matched retrospective cohort selected from the prospective arm of the APR. This cohort is assembled retrospectively in order to appropriately match the subjects by calendar time and the correlates of exposure, with exposure being defined as being on FTC/TDF for PrEP vs being exposed to other ARVs. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Number of Subjects and Subject Selection: 400 HIV-1 uninfected women who are exposed to FTC/TDF for PrEP during pregnancy stratified into 200 who decide to continue and 200 who choose to discontinue FTC/TDF for PrEP. A propensity score-matched comparison group of equal size (400 women) of HIV-positive pregnant women taking antiretrovirals. All evaluable subjects enrolled into the APR who fulfill the inclusion criteria for the target cohort will be selected. Every year at the time of building the annual report for this study, a propensity score matched comparison group will be selected on a 1:1 ratio among all pregnant women on antiretrovirals.
Key inclusion criteria (7 listed)
- Pregnant women
- Part of the prospective arm of the APR Target Group Inclusion Criteria
- HIV-1 Negative
- Choosing to remain on FTC/TDF for PrEP during pregnancy or,
- Choosing to discontinue FTC/TDF for PrEP during pregnancy Comparison Group Inclusion Criteria
Key exclusion criteria (2 listed)
- This is an observational nested study and will monitor all reported exposures without intervention/exclusion.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP
Time frame: Year 1
1 secondary outcome
Pregnancy outcomes in HIV-1 uninfected women who choose to continue or discontinue FTC/TDF for PrEP during their pregnancy as well as HIV-infected women treated with antiretrovirals
Time frame: Years 1, 2, and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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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.
Gilead Study Director study director
Gilead Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Gilead Sciences at 1 site in United States.
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 7 inclusion and 2 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Presence or absence of congenital malformations among infants born to HIV-1 uninfected women on FTC/TDF for PrEP (time frame: Year 1). 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 30 Mar 2018.