NCT02741557

Bioequivalence Study of a Fixed-dose Combination (FDC) of Dolutegravir (DTG) and Rilpivirine (RPV)

Completed Phase 1 Last updated 15 July 2019

What this trial tests

Phase 1 trial testing DTG in Infection, Human Immunodeficiency Virus in 118 participants. Completed in 24 October 2016.

Timeline

11 May 2016

Primary endpoint
24 October 2016

24 October 2016

Quick facts

Lead sponsor	ViiV Healthcare
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	118
Start date	11 May 2016
Primary completion	24 October 2016
Estimated completion	24 October 2016
Sites	1 location across United States

Drugs / interventions tested

• DTG — full drug profile →
• RPV
• DTG/RPV FDC — full drug profile →

Conditions studied

• Infection, Human Immunodeficiency Virus — all drugs for Infection, Human Immunodeficiency Virus →
• HIV Infections — all drugs for HIV Infections →

Sponsor

ViiV Healthcare — full company profile →

Who can join

Adults 18 to 55, any sex, with Infection, Human Immunodeficiency Virus or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the bioequivalence between Fixed-dose Combination (FDC) tablet formulation of Dolutegravir (DTG) 50 milligrams (mg) and Rilpivirine (RPV) 25 mg versus co-administration of the separate tablet formulations of DTG 50 mg plus RPV 25 mg, in the fed state. This pivotal bioequivalence study, is to serve as a pharmacokinetic (PK) bridge to the ongoing Phase 3 trials with the separate agents. This study will be conducted under fed conditions to appropriately mimic the conditions in the Phase 3 trials. This is a single-center, randomized, open-label, 2-period, single-dose, crossover study. A minimum of 86 healthy adult subjects will be randomized such that a minimum of approximately 82 evaluable subjects complete the study. The total duration of participation of a subject in this study will be approximately 8 weeks which includes a screening visit within 30 days prior to the first dose of study drug, two treatment periods each with a single dose of study drug and a follow-up visit within 12-17 days after the last dose of study drug. There will be a washout of at least 21 days between each dose of study drug.

A blinded (for treatment) review of DTG and RPV plasma concentration data for approximately the first 40 subjects will be conducted. If the within-subject coefficients of variation (CVw%) for either DTG or RPV maximal drug concentration (Cmax) values are \>=31%; a sample size re-estimation will be employed and additional subjects (beyond the 86 planned) will be randomized for treatment in the study. Following the re-estimation, it is possible that up to approximately 154 healthy adult subjects (68 new subjects in addition to the planned 86 subjects above) will be randomized such that a maximum of approximately 146 evaluable subjects could complete the study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bioequivalence of a Fixed-Dose Combination Tablet of the Complete Two-Drug Regimen of Dolutegravir and Rilpivirine for Treatment of HIV-1 Infection.
   Mehta R, Wolstenholme A, Di Lullo K, Fu C, et al · · 2018 · cited 8× · PMID 29987139 · DOI 10.1128/aac.00748-18
2. Application of sample size re-estimation in clinical trials: A systematic review.
   Mano H, Tanaka Y, Orihara S, Moriya J. · · 2023 · cited 4× · PMID 37842317 · DOI 10.1016/j.conctc.2023.101210