Trials Sponsors Conditions Drugs Pricing

Conditions

Infections, Human Immunodeficiency Virus and Herpesviridae

Outcome Measures

Primary Outcomes (6)

GSK1265744 safety and tolerability parameters including: the collection of adverse events
12 weeks
Change from baseline values in clinical laboratory assessments
12 weeks
Change from baseline for Electrocardiogram (ECG) assessments
12 weeks
Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate)
12 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant
12 weeks

Secondary Outcomes (4)

Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks.
12 weeks
Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
12 weeks
GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality
12 weeks
GSK1265744 concentrations in cervicovaginal fluid (CVF), cervical tissue (CT), vaginal tissue (VT), rectal tissue (RT), and blood plasma and ratio of CVF, CT, VT, and RT concentration to blood plasma
Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12

Study Arms (9)

Cohort 1

EXPERIMENTAL

100 mg GSK1265744 injectable suspension or placebo, intramuscular dosing

Drug: GSK1265744 injectable suspensionOther: Placebo to match injectable suspension

Cohort 2

EXPERIMENTAL

200 mg GSK1265744 injectable suspension or placebo, intramuscular dosing

Drug: GSK1265744 injectable suspensionOther: Placebo to match injectable suspension

Cohort 3

EXPERIMENTAL

Interventions

GSK1265744 injectable suspensionDrug

200 milligram per milliliter sterile solution for injection

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 7Cohort 8Cohort 9

Placebo to match injectable suspension

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.

Sponsors & Collaborators

GlaxoSmithKline
Industrycollaborator
ViiV Healthcare
Industrylead

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

cabotegravir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital Diseases

Study Officials

GSK Clinical Trials
ViiV Healthcare
STUDY DIRECTOR

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

December 25, 2012

Study Start

September 2010

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

As a result of the medical interview, physical examination, or screening investigations, the Investigator considers the subject unfit for the study.
A positive pre-study Hepatitis B surface antigen, positive Hepatitis C antibody, or positive test for HIV antibody result within 3 months of screening
High-risk behavior for Human Immunodeficiency Virus (HIV) infection including one of the following risk factors within six months before entering the study (day 1): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation. If heparin is used during pharmacokinetics sampling, subjects with a history or sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
A positive pre-study drug screen.
History of regular alcohol consumption within 6 months of the study defined as:
An average weekly intake of greater than 14 drinks for males or greater than 7 drinks for females.
Unwilling to abstain from alcohol from 48 hours prior to admission to study site (Day -1) until discharge from clinic and for 48 hours prior to drawing clinical laboratory tests (Day 7, Day 14, Week 3, Week 4, Week 6, Week 8, Week 12, and follow-up \[if necessary\]).
Where participation in the study would result in donation of blood or blood products in excess of 500 milliliters (mL) within a 56 day period
Lactating females.
The subject has an underlying skin disease or disorder (i.e. infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria).
The subject has a tattoo or other dermatological condition overlying the gluteus and/or abdominal region which may interfere with interpretation of injection site reactions.
+4 more criteria

A Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intramuscular and Subcutaneous Long Acting GSK1265744 in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (4)

Study Arms (9)

Cohort 1

Cohort 2

Cohort 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

Cohort 9

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (4)

Study Arms (9)

Cohort 1

Cohort 2

Cohort 3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Cohort 4

Cohort 5

Cohort 6

Cohort 7

Cohort 8

Cohort 9

You may not qualify if:

Source record