Relative Oral Bioavailability Study of Different Fixed Dose Combinations of Dolutegravir and Rilpivirine in Healthy Subjects

NCT02373930 | Completed Phase 1

• 1 other identifier: 201674
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of human immunodeficiency virus (HIV) infection requires daily oral administration of a combination of antiretroviral drugs to reduce the patient's HIV levels. Dolutegravir (DTG), a HIV-1 integrase inhibitor (INI), and Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are approved for the treatment of HIV infection. This study is aimed to evaluate the relative bioavailability and food effect of single doses of several experimental fixed dose combination (FDC) tablets of Dolutegravir 50 milligrams (mg) and Rilpivirine 25 mg (DTG/RPV 50 mg/25 mg) relative to co-administration of a single dose of the reference single entity products (DTG 50 mg and RPV 25 mg) in healthy adult subjects. This is a 2-part study. Part 1 will be conducted as a randomized, open label, 3-way, crossover design in 24 subjects. Part 1 will evaluate the relative bioavailability of up to 4 test formulations relative to the reference single entity products administered in fed state. Part 2 will be conducted as a randomized, open-label, 3-way crossover design in 3 distinct cohorts each with 12 subjects. Part 2 will evaluate the relative bioavailability of up to 3 most promising FDC formulation selected from Part 1 (DTG/RPV FDC-1, DTG/RPV FDC-2, DTG/RPV FDC-3) administered in fasted and fed state. Subjects will also receive the reference treatment from Part 1 co-administered under fasted conditions. This study will consist of a screening visit, three treatment periods each with a single dose of study drug separated by a washout of at least 9 days and a follow-up visit. The total duration of participation of a subject in this study will be approximately 10 weeks.

Conditions

Infection, Human Immunodeficiency Virus

Keywords

Dolutegravir; safety; Rilpivirine; fixed dose combination; relative bioavailability

Outcome Measures

Primary Outcomes (3)

• Composite of pharmacokinetic (PK) parameters of a single dose of DTG and RPV administered together in a FDC tablet compared to co-administration of the single-entity DTG and RPV products in fed state (Part 1)

  PK parameters will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC \[0-Infinity\]), maximum observed concentration (Cmax) and apparent oral clearance (CL/F)

  Part 1: Pre-dose and 0.25 hours (h), 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

• Composite of PK parameters of a single dose of DTG and RPV administered together in a FDC tablet compared to co-administration of the single-entity DTG and RPV products in fasted state (Part 2)

  PK parameters will include AUC (0-Infinity), Cmax and CL/F

  Part 2: Pre-dose and 0.25 h, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

• Composite of PK parameters of DTG and RPV to evaluate the effect of food on the bioavailability of selected FDC formulation(s) of DTG and RPV (Part 2)

  PK parameters will include AUC (0-Infinity), Cmax and CL/F

  Part 2: Pre-dose and 0.25 h, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

Secondary Outcomes (6)

• Composite of PK parameters of a single dose of DTG and RPV administered together in a FDC tablet compared to co-administration of the single-entity DTG and RPV products in fed state (Part 1)

  Part 1: Pre-dose and 0.25 h, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

• Composite of PK parameters of a single dose of DTG and RPV administered together in a FDC tablet compared to co-administration of the single-entity DTG and RPV products in fasted state (Part 2)

  Part 2: Pre-dose and 0.25 h, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

• Composite of PK parameters of DTG and RPV to evaluate the effect of food on the bioavailability of selected FDC formulation(s) of DTG and RPV (Part 2)

  Part 2: Pre-dose and 0.25 h, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 6 h, 7 h, 9 h, 12 h, 16 h, 24 h, 48 h, 72 h, 120 h, and 168 hours post-dose in each treatment period.

• Change from baseline in vital signs

  Part 1 and 2: Baseline (Day 1) and up to Day 35

• Number of subjects with adverse events (AEs)

  Part 1 and 2: Up to Day 35

Study Arms (15)

Part 1 Cohort 1- Sequence 1

EXPERIMENTAL

Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS) and Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM

Part 1 Cohort 1- Sequence 2

EXPERIMENTAL

Each subject will receive a single dose of Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ), Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) and Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ

Part 1 Cohort 1- Sequence 3

EXPERIMENTAL

Each subject will receive a single dose of Treatment B (DTG/RPV 50 mg/25 mg: Product Code AS), Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK) and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AK

Part 1 Cohort 1- Sequence 4

EXPERIMENTAL

Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM) and Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ

Part 1 Cohort 1- Sequence 5

EXPERIMENTAL

Each subject will receive a single dose of Treatment C (DTG/RPV 50 mg/25 mg: Product Code AM), Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), and Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK) in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AK

Part 1 Cohort 1- Sequence 6

EXPERIMENTAL

Each subject will receive a single dose of Treatment E (DTG/RPV 50 mg/25 mg: Product Code AK), Treatment D (DTG/RPV 50 mg/25 mg: Product Code AQ) and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet), in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication. All treatments will be administered in fed state.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK

Part 2 Cohort 2- Sequence 1

EXPERIMENTAL

Each subject will receive a single dose of Treatment F (DTG/RPV FDC-1) in fasted state, Treatment F (DTG/RPV FDC-1) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 2- Sequence 2

EXPERIMENTAL

Each subject will receive a single dose of Treatment F (DTG/RPV FDC-1) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment F (DTG/RPV FDC-1) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 2- Sequence 3

EXPERIMENTAL

Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state, Treatment F (DTG/RPV FDC-1) in fasted state and Treatment F (DTG/RPV FDC-1) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 3- Sequence 4

EXPERIMENTAL

Each subject will receive a single dose of Treatment G (DTG/RPV FDC-2) in fasted state, Treatment G (DTG/RPV FDC-2) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 3- Sequence 5

EXPERIMENTAL

Each subject will receive a single dose of Treatment G (DTG/RPV FDC-2) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment G (DTG/RPV FDC-2) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 3- Sequence 6

EXPERIMENTAL

Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment G (DTG/RPV FDC-2) fasted state and Treatment G (DTG/RPV FDC-2) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 4- Sequence 7

EXPERIMENTAL

Each subject will receive a single dose of Treatment H (DTG/RPV FDC-3) in fasted state, Treatment H (DTG/RPV FDC-3) in fed state and Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 4- Sequence 8

EXPERIMENTAL

Each subject will receive a single dose of Treatment H (DTG/RPV FDC-3) in fed state, Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment H (DTG/RPV FDC-3) in fasted state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Part 2 Cohort 4- Sequence 9

EXPERIMENTAL

Each subject will receive a single dose of Treatment A (DTG 50 mg tablet plus RPV 25 mg tablet) in fasted state and Treatment H (DTG/RPV FDC-3) fasted state and Treatment H (DTG/RPV FDC-3) in fed state in period 1, period 2 and period 3 respectively with a washout period of \>=9 days between doses of study medication.

Drug: DTG 50 mg; Drug: RPV 25 mg; Drug: DTG/RPV 50 mg/25 mg: Product Code AS; Drug: DTG/RPV 50 mg/25 mg: Product Code AM; Drug: DTG/RPV 50 mg/25 mg: Product Code AQ; Drug: DTG/RPV 50 mg/25 mg: Product Code AK; Drug: DTG/RPV 50 mg/25 mg: Product Code AR

Interventions

DTG 50 mg DRUG

Dolutegravir will be supplied as a white, film-coated, round tablet with a unit dose strength of 50 mg to be administered orally

Part 1 Cohort 1- Sequence 1; Part 1 Cohort 1- Sequence 2; Part 1 Cohort 1- Sequence 3; Part 1 Cohort 1- Sequence 4; Part 1 Cohort 1- Sequence 5; Part 1 Cohort 1- Sequence 6; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

RPV 25 mg DRUG

Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally

Part 1 Cohort 1- Sequence 1; Part 1 Cohort 1- Sequence 2; Part 1 Cohort 1- Sequence 3; Part 1 Cohort 1- Sequence 4; Part 1 Cohort 1- Sequence 5; Part 1 Cohort 1- Sequence 6; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

DTG/RPV 50 mg/25 mg: Product Code AS DRUG

DTG/RPV will be supplied as a pink, film coated, round biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Part 1 Cohort 1- Sequence 1; Part 1 Cohort 1- Sequence 2; Part 1 Cohort 1- Sequence 3; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

DTG/RPV 50 mg/25 mg: Product Code AM DRUG

DTG/RPV will be supplied as a pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Part 1 Cohort 1- Sequence 1; Part 1 Cohort 1- Sequence 4; Part 1 Cohort 1- Sequence 5; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

DTG/RPV 50 mg/25 mg: Product Code AQ DRUG

DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Part 1 Cohort 1- Sequence 2; Part 1 Cohort 1- Sequence 4; Part 1 Cohort 1- Sequence 6; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

DTG/RPV 50 mg/25 mg: Product Code AK DRUG

DTG/RPV will be supplied as pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Part 1 Cohort 1- Sequence 3; Part 1 Cohort 1- Sequence 5; Part 1 Cohort 1- Sequence 6; Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

DTG/RPV 50 mg/25 mg: Product Code AR DRUG

DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally

Part 2 Cohort 2- Sequence 1; Part 2 Cohort 2- Sequence 2; Part 2 Cohort 2- Sequence 3; Part 2 Cohort 3- Sequence 4; Part 2 Cohort 3- Sequence 5; Part 2 Cohort 3- Sequence 6; Part 2 Cohort 4- Sequence 7; Part 2 Cohort 4- Sequence 8; Part 2 Cohort 4- Sequence 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history, electrocardiogram \[ECG\]).

You may not qualify if:

• Body weight \>=50 kilograms (kg) (110 pounds \[lbs\]) for men and \>=45 kg (99 lbs) for women and body mass index (BMI) within the range 18.5-31.0 kg/square meter (m\^2) (inclusive).
• Male or Female- Female: Female subject of non-reproductive potential : is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: Pre-menopausal females with one of the following: documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral oophorectomy.
• Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
• Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) modified list of highly effective methods for avoiding pregnancy in females of reproductive potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives (10 days) after the last dose of study medication and completion of the follow-up visit.
• GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP)
• This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis.
• Intrauterine device that meets the standard operating procedure (SOP) effectiveness criteria including a \<1% rate of failure per year, as stated in the product label.
• Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
• Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository).
• These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
• Male:
• Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until \[at least five half-lives of study medication OR for a cycle of spermatogenesis following five terminal half-lives\] after the last dose of study medication.
• Vasectomy with documentation of azoospermia.
• Male condom plus partner use of one of the contraceptive options below:
• Contraceptive subdermal implant that meets the SOP effectiveness criteria including a \<1% rate of failure per year, as stated in the product label.

Sponsors & Collaborators

• ViiV Healthcare: lead
• Janssen Pharmaceuticals: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

dolutegravir

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 27, 2016

Record last verified: 2016-06

Locations

US (1)