A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women.

ING200336: A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003527-11-ES

Enrollment

Registered

2014-03-17

Start date

2014-05-13

Completion date

Unknown

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-infection MedDRA version: 17.0 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 100000004862

Interventions

Product Name: dolutegravir/abacavir/lamivudine fixed dose combination tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DOLUTEGRAVIR CAS Number: 1051375-19-9 Current Sponsor code: GS

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV infected females participating in ING117172 on the DTG/ABC/3TC treatment arm who became pregnant with a singleton and have not met any safety or confirmed virologic withdrawal criteria; 2. Signed and dated written informed consent is obtained from the subject or the subject's legal representative prior to screening; 3. Willingness and intent to continue pregnancy; 4. Willingness to continue to receive DTG/ABC/3TC FDC; 5. Willingness to enter the Antiretroviral Pregnancy Registry; 6. Willingness to share medical information about herself and her infant for collection of delivery and infant outcomes as it relates to this study; 7. Subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusionary medical conditions 1. History of allergy/sensitivity to DTG, ABC and/or 3TC; 2. History of severe pre-clampsia, eclampsia, or HELLP; 3. Any evidence of an active Center for Disease Control and Prevention (CDC) Category C disease [CDC, 1993], except cutaneous Kaposi?s sarcoma not requiring systemic therapy or historic or current CD4+ cell levels 2 urine protein (dipstick), serum creatinine, total bilirubin, ALT or AST at the time of the screening lab; 14. Subject has CrCL of <50 mL/min via Cockroft-Gault method at the time of the screening visit.

Design outcomes

Primary

Measure	Time frame
Main Objective: Mother: - To describe the total plasma DTG PK parameters with the DTG/ABC/3TC FDC during Weeks 18-26, Weeks 30 ? 36 of the third trimester of the pregnancy and 8- 12 weeks postpartum; - To further characterize the safety and tolerability of DTG/ABC/3TC FDC when used during pregnancy.;Secondary Objective: Mother: - To assess the antiviral activity of the DTG/ABC/3TC FDC when administered during pregnancy; - To assess the immunologic activity of DTG/ABC/3TC FDC; - To assess the incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria; - To evaluate the unbound DTG concentrations in plasma during Weeks 18-26 and Weeks 30-36 of the pregnancy and 8-12 weeks postpartum; - To compare the DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery; - To characterize birth outcomes; - To characterize pregnancy outcomes. Infant: - To characterize infant outcomes at birth;;Primary end point(s): DTG PK parameters with the DTG/ABC/3TC FDC during pregnancy and 8-12 weeks postpartum; safety;Timepoint(s) of evaluation of this end point: Weeks 18-26, Weeks 30 -36 of the third trimester of the pregnancy and 8-12 weeks postpartum	—

Measure

Time frame

Main Objective: Mother: - To describe the total plasma DTG PK parameters with the DTG/ABC/3TC FDC during Weeks 18-26, Weeks 30 ? 36 of the third trimester of the pregnancy and 8- 12 weeks postpartum; - To further characterize the safety and tolerability of DTG/ABC/3TC FDC when used during pregnancy.;Secondary Objective: Mother: - To assess the antiviral activity of the DTG/ABC/3TC FDC when administered during pregnancy; - To assess the immunologic activity of DTG/ABC/3TC FDC; - To assess the incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria; - To evaluate the unbound DTG concentrations in plasma during Weeks 18-26 and Weeks 30-36 of the pregnancy and 8-12 weeks postpartum; - To compare the DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery; - To characterize birth outcomes; - To characterize pregnancy outcomes. Infant: - To characterize infant outcomes at birth;;Primary end point(s): DTG PK parameters with the DTG/ABC/3TC FDC during pregnancy and 8-12 weeks postpartum; safety;Timepoint(s) of evaluation of this end point: Weeks 18-26, Weeks 30 -36 of the third trimester of the pregnancy and 8-12 weeks postpartum

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Secondary

Measure	Time frame
Secondary end point(s): Mother: - antiviral activity of the DTG/ABC/3TC FDC when administeredduring pregnancy; - immunologic activity of DTG/ABC/3TC FDC; - incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria; - unbound DTG concentrations in plasma during Weeks 18-26, Weeks 30-36 of the pregnancy and 8-12 weeks postpartum; - DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery; - birth outcomes; - pregnancy outcomes - Incidence and severity of AEs and laboratory abnormalities; - Absolute values and changes over time in laboratory parameters; - Proportion of subjects who discontinue treatment due to AEs. Infant: - outcomes at birth;;Timepoint(s) of evaluation of this end point: PK: Weeks 18-26 & Weeks 30-36 of pregnancy, at delivery, Weeks 8-12 post-partum, q 12 weeks thereafter	—

Measure

Time frame

Secondary end point(s): Mother: - antiviral activity of the DTG/ABC/3TC FDC when administeredduring pregnancy; - immunologic activity of DTG/ABC/3TC FDC; - incidence of treatment-emergent genotypic and phenotypic resistance in subjects who meet confirmed virologic withdrawal criteria; - unbound DTG concentrations in plasma during Weeks 18-26, Weeks 30-36 of the pregnancy and 8-12 weeks postpartum; - DTG concentrations in plasma from cord blood with those in maternal plasma at the time of delivery; - birth outcomes; - pregnancy outcomes - Incidence and severity of AEs and laboratory abnormalities; - Absolute values and changes over time in laboratory parameters; - Proportion of subjects who discontinue treatment due to AEs. Infant: - outcomes at birth;;Timepoint(s) of evaluation of this end point: PK: Weeks 18-26 & Weeks 30-36 of pregnancy, at delivery, Weeks 8-12 post-partum, q 12 weeks thereafter

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Countries

Argentina, Canada, France, Mexico, Portugal, Puerto Rico, Russian Federation, South Africa, Spain, Thailand, United Kingdom, United States

Contacts

Public ContactCentro de Información

GlaxoSmithKline

es-ci@gsk.com34902202700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026