Long-term clinical follow up study for subjects who had previously taken the experimental drug GSK2248761

Observational Drug Exposure Registry for Long-Term Follow-Up of Subjects Exposed to GSK2248761

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003303-38-DE

Enrollment

Registered

2011-08-09

Start date

2011-10-13

Completion date

Unknown

Last updated

2013-07-29

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

Conditions

HIV-1 infected adults MedDRA version: 14.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: GSK2248761 Product Code: GSK2248761 Pharmaceutical Form: Capsule INN or Proposed INN: Fosdevirine CAS Number: 1018450-26-4 Current Sponsor code: GSK2248761 Other descriptive name: IDX-89

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All subjects who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and received GSK2248761 will be targeted for enrollment in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not applicable.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the study is to collect and monitor data on all subjects who previously received GSK2248761 while enrolled in the Phase 2b studies SGN113399 or SGN113404 evaluating GSK2248761. There will be no formal hypotheses tested, and the data collected will be utilized to build individual subject narratives for each subject. ;Secondary Objective: Not applicable;Primary end point(s): No outcomes are defined for analytical purposes. Data will be collected quarterly. These data points include adverse event (AE) information, HIV disease details (viral load, CD4 cell count), newly occurring diseases of interest, and concomitant medications. The purpose of this data is for generating detailed subject narratives and AE listing reports. ;Timepoint(s) of evaluation of this end point: Data will be collected quarterly.	—

Measure

Time frame

Main Objective: The objective of the study is to collect and monitor data on all subjects who previously received GSK2248761 while enrolled in the Phase 2b studies SGN113399 or SGN113404 evaluating GSK2248761. There will be no formal hypotheses tested, and the data collected will be utilized to build individual subject narratives for each subject. ;Secondary Objective: Not applicable;Primary end point(s): No outcomes are defined for analytical purposes. Data will be collected quarterly. These data points include adverse event (AE) information, HIV disease details (viral load, CD4 cell count), newly occurring diseases of interest, and concomitant medications. The purpose of this data is for generating detailed subject narratives and AE listing reports. ;Timepoint(s) of evaluation of this end point: Data will be collected quarterly.

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

France, Germany, Romania, United States

Contacts

Public ContactClinical Trials Helpdesk

GlaxoSmithKline Research & Development

GSKClinicalSupportHD@gsk.com+44208990 4466

Outcome results

None listed

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