HIV InfectionsNCT03564613
Study to Define Safety and Effectiveness of Dolutegravir (DTG) Use in Human Immunodeficiency Virus (HIV) Positive Pregnant Women
An observational study of HIV Infections, run by ViiV Healthcare at 1 site in Spain.
Trial summary
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- DTG
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- 18 Nov 2019to 30 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.
Who may be able to join
- HIV positive pregnant women aged 18 years and over on DTG
- With no maternal or birth outcomes yet
- Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Barcelona, 08041
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: DOLOMITE NEAT ID Network Study: A Prospective, Multi-site Observational Study to Define the Safety and Effectiveness of Dolutegravir Use in HIV Positive Pregnant Women
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.
- Conditions
- HIV Infections
- Being tested
- DTG
- Keywords
- HIV, Dolutegravir, Europe, NEAT ID, pregnancy, Safety, Antiretroviral
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTGDrug
Subjects with DTG exposure during any trimester will be included
| Study group | Role | What they receive |
|---|---|---|
| HIV positive pregnant women | Data from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included. Receives: Drug: DTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of female subjects with spontaneous abortion
Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.
Measured: Up to 1 year
Number of female subjects with induced abortion
Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
Measured: Up to 1 year
Number of female subjects giving still births
Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams.
Measured: Up to 1 year
Number of female subjects with multiple births
Number of female subjects giving multiple births will be reported.
Measured: Up to 1 year
Number of female subjects with type of deliveries
The different type of deliveries will be summarized.
Measured: Up to 1 year
Maternal viral load (VL) at delivery
The maternal viral load at the time of delivery will be summarized.
Measured: Up to 1 year
Number of infants with birth defects
Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.
Measured: Up to 1 year
Gestational age
Number of females with birth collected data for gestational age as a measure of birth defects will be reported.
Measured: Up to 1 year
Birth weight
Number of females with birth collected data for birth weight as a measure of birth defects will be reported.
Measured: Up to 1 year
Number of female subjects giving premature births
Premature birth is defined as birth of live infant at <32 weeks gestation
Measured: Up to 1 year
Number of female subjects giving live births
Number of female subjects giving live births will be reported.
Measured: Up to 1 year
Infants with low birth weight
Low birth weight is defined as birth weight of <2500 grams.
Measured: Up to 1 year
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants
APGAR score in infants as a measure of birth defects will be calculated.
Measured: Up to 1 year
HIV status of Infants
Infant's HIV status as a measure of birth defects will be reported.
Measured: Up to 1 year
Secondary outcomes (4)
Number of female subjects with drug related Adverse Events and Serious Adverse Events
Number of females with all drug related Adverse Events and Serious Adverse Events will be reported. These will be categorized by trimester of initiation.
Measured: Up to 1 year
Rate of DTG discontinuation in pregnant women
Number of pregnant females with discontinuation of DTG will be reported.
Measured: Up to 1 year
Number of participants who discontinued DTG
Reasons for DTG discontinuation will be summarized. Number of participants who discontinued DTG will be reported.
Measured: Up to 1 year
Number of participants with VL at discontinuation
VL at discontinuation will be summarized to assess suppression. Number of participants with VL at discontinuation will be reported.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start18 Nov 2019
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (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.
- More trials run by ViiV HealthcareThe 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564613
- Sponsor's protocol ID
- 208759
- Status last verified
- May 2024
- First submitted
- 11 Jun 2018
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLOMITE NEAT ID Network Study: A Prospective, Multi-site Observational Study to Define the Safety and Effectiveness of Dolutegravir Use in HIV Positive Pregnant Women
- ClinicalTrials.gov ID
- NCT03564613
- Acronym / sponsor ID
- 208759
- Conditions
- HIV Infections
- Keywords
- HIV, Dolutegravir, Europe, NEAT ID, pregnancy, Safety, Antiretroviral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 21 Jun 2018 (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.
The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive pregnant women | – | Drug: DTGData from approximately 250 HIV positive pregnant women with exposure to DTG from potential investigational sites across Europe will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately, 250 HIV positive pregnant women having exposure to DTG from potential NEAT ID investigational sites across Europe will be enrolled.
Key inclusion criteria (3 listed)
- HIV positive pregnant women aged 18 years and over on DTG
- With no maternal or birth outcomes yet
- Subjects are able and willing to provide written informed consent and comply with any safety reporting requirements.
Key exclusion criteria (1 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 |
|---|---|---|
| DTGSubjects with DTG exposure during any trimester will be included | Drug | HIV positive pregnant women |
Primary outcome
Number of female subjects with spontaneous abortion
Time frame: Up to 1 year
Spontaneous abortion is defined as death of a fetus or expulsion of the products of conception before 22 weeks gestation.
Number of female subjects with induced abortion
Time frame: Up to 1 year
Induced abortion is defined as voluntary termination of pregnancy before 22 weeks gestation.
Number of female subjects giving still births
Time frame: Up to 1 year
Still birth is defined as the death of a fetus occurring at 22 weeks of gestation or more, or for situations in which the gestational age is unavailable, a fetus weighing at least 500 grams.
Number of female subjects with multiple births
Time frame: Up to 1 year
Number of female subjects giving multiple births will be reported.
Number of female subjects with type of deliveries
Time frame: Up to 1 year
The different type of deliveries will be summarized.
Maternal viral load (VL) at delivery
Time frame: Up to 1 year
The maternal viral load at the time of delivery will be summarized.
Number of infants with birth defects
Time frame: Up to 1 year
Birth defects will be classified according to World Health Organization's International Classification of Diseases, Tenth Revision.
Gestational age
Time frame: Up to 1 year
Number of females with birth collected data for gestational age as a measure of birth defects will be reported.
Birth weight
Time frame: Up to 1 year
Number of females with birth collected data for birth weight as a measure of birth defects will be reported.
Number of female subjects giving premature births
Time frame: Up to 1 year
Premature birth is defined as birth of live infant at <32 weeks gestation
Number of female subjects giving live births
Time frame: Up to 1 year
Number of female subjects giving live births will be reported.
Infants with low birth weight
Time frame: Up to 1 year
Low birth weight is defined as birth weight of <2500 grams.
Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score in infants
Time frame: Up to 1 year
APGAR score in infants as a measure of birth defects will be calculated.
HIV status of Infants
Time frame: Up to 1 year
Infant's HIV status as a measure of birth defects will be reported.
4 secondary outcomes
Number of female subjects with drug related Adverse Events and Serious Adverse Events
Time frame: Up to 1 year
Rate of DTG discontinuation in pregnant women
Time frame: Up to 1 year
Number of participants who discontinued DTG
Time frame: Up to 1 year
Number of participants with VL at discontinuation
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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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.
GSK Clinical Trials study director
ViiV Healthcare
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 Infections, run by ViiV Healthcare at 1 site in Spain.
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 1 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 17 May 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of female subjects with spontaneous abortion (time frame: Up to 1 year). The study lists 14 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 17 May 2024.