Trial Outcomes & Findings for Drug Exposure Registry for GSK2248761, an Investigational NNRTI (NCT NCT01458132)

Last Updated: 2019-09-11

Results Overview

In the registry study from start to the end of follow-up, the number of participants who experienced seizure were reported. This was done to evaluate to test the time-efficiency and cost-efficiency for a long term, non-interventional study.

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

Up to 17 months

Results posted on

2019-09-11

Participant Flow

The study was conducted from 06 September 2011 to 25 February 2013, at 19 sites in 4 countries, France, Romania, United States, and Germany.

Of the 35 Fosdevirine -exposed participants, 19 consented to enroll in the registry, including 4 of the 5 seizure participants and 15 from the non-seizure group.

Participant milestones

Participant milestones
Measure	Participants Without Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 milligram (mg), for atleast four weeks in the Phase 2b trials.	Participants With Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Overall Study STARTED	15	4
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	15	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants Without Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 milligram (mg), for atleast four weeks in the Phase 2b trials.	Participants With Seizure Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Overall Study Other	15	3

Baseline Characteristics

Drug Exposure Registry for GSK2248761, an Investigational NNRTI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Without Seizure n=15 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine ) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Participants With Seizure n=4 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 and experienced seizure during the follow-up period , after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 17 months

Population: All Subject Population, defined as all participants, who consented to participate in the registry study.

Outcome measures

Outcome measures
Measure	Participants Without Seizure n=15 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Participants With Seizure n=4 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Number of Participants With Occurrence of Seizure	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Upto 17 months

Population: All Subject Population.

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.

Outcome measures

Outcome measures
Measure	Participants Without Seizure n=15 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Participants With Seizure n=4 Participants Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Number of Participants With Serious Adverse Event (SAE) and Adverse Event (AE) Any AE	15 Participants	4 Participants
Number of Participants With Serious Adverse Event (SAE) and Adverse Event (AE) Any SAE	1 Participants	0 Participants

Adverse Events

Participants Without Seizure

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Participants With Seizure

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants Without Seizure n=15 participants at risk Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Participants With Seizure n=4 participants at risk Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Infections and infestations Staphylococcal infection	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Participants Without Seizure n=15 participants at risk Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and did not experience seizure during the follow-up period, after exposure to Fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.	Participants With Seizure n=4 participants at risk Participants who were previously randomized in the Phase 2b studies SGN113399 or SGN113404 (randomized to Fosdevirine) and experienced seizure during the follow-up period, after exposure to fosdevirine, at 100 or 200 mg, for atleast four weeks in the Phase 2b trials.
Respiratory, thoracic and mediastinal disorders Bronchitis	40.0% 6/15 • Up to 17 months All Subject Population was used	25.0% 1/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Up to 17 months All Subject Population was used	25.0% 1/4 • Up to 17 months All Subject Population was used
Blood and lymphatic system disorders Anaemia	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Arthralgia	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Nervous system disorders Convulsion	0.00% 0/15 • Up to 17 months All Subject Population was used	25.0% 1/4 • Up to 17 months All Subject Population was used
Gastrointestinal disorders Diarrhoea	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Infections and infestations Eye abscess	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Infections and infestations Gastroenteritis salmonella	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Surgical and medical procedures Hip arthroplasty	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/15 • Up to 17 months All Subject Population was used	25.0% 1/4 • Up to 17 months All Subject Population was used
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Respiratory, thoracic and mediastinal disorders Pharyngitis	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Renal and urinary disorders Pollakiuria	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Immune system disorders Rhinitis allergic	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Skin and subcutaneous tissue disorders Skin lesion	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Skin and subcutaneous tissue disorders Skin ulcer	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Psychiatric disorders Tobacco withdrawal symptom	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used
Infections and infestations Vaginal infection	6.7% 1/15 • Up to 17 months All Subject Population was used	0.00% 0/4 • Up to 17 months All Subject Population was used