NCT02938520 - Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants | Biotech Hunter

Enrollment

631

Participants

Timeline

Start Date

October 27, 2016

Primary Completion Date

August 30, 2018

Study Completion Date

December 31, 2025

Conditions

HIV Infections

Interventions

DRUG

Cabotegravir (CAB) tablet

It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat.

DRUG

Rilpivirine (RPV) tablet

"It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose."

DRUG

Cabotegravir - Injectable Suspension (CAB LA)

It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.

DRUG

Rilpivirine - Injectable Suspension (RPV LA)

It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.

DRUG

ABC/DTG/3TC STR - Tablet

"It is a purple, biconvex, oval, tablet debossed with 572 Tri on one side, film-coated tablet contains abacavir sulphate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg dolutegravir, and 300 mg of lamivudine. The inactive ABC/DTG/3TC tablet ingredients include D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."

DRUG

DTG Tablet

"It is a yellow, round, biconvex, 50 mg film-coated tablet debossed with SV 572 on one side and 50 on the other side. Each tablet of DTG also contains the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate."

Trial Locations (108)

1055

GSK Investigational Site, Middelburg

2113

GSK Investigational Site, Johannesburg

4001

GSK Investigational Site, Durban

4052

GSK Investigational Site, Durban

7925

GSK Investigational Site, Cape Town

9301

GSK Investigational Site, Bloemfontein

9400

GSK Investigational Site, Winnie Mandela

10029

GSK Investigational Site, New York

10439

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

13003

GSK Investigational Site, Marseille

15006

GSK Investigational Site, A Coruña

15405

GSK Investigational Site, Ferrol

18016

GSK Investigational Site, Granada

20005

GSK Investigational Site, Washington D.C.

20127

GSK Investigational Site, Milan

20146

GSK Investigational Site, Hamburg

20157

GSK Investigational Site, Milan

20246

GSK Investigational Site, Hamburg

20900

GSK Investigational Site, Monza MB

24501

GSK Investigational Site, Lynchburg

25123

GSK Investigational Site, Brescia

28040

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

28702

GSK Investigational Site, San SebastiAn de Los Rey

30003

GSK Investigational Site, Murcia

30120

GSK Investigational Site, Murcia

30312

GSK Investigational Site, Atlanta

30625

GSK Investigational Site, Hanover

31201

GSK Investigational Site, Macon

32806

GSK Investigational Site, Orlando

33316

GSK Investigational Site, Fort Lauderdale

35294

GSK Investigational Site, Birmingham

38010

GSK Investigational Site, Santa Cruz de Tenerife

38320

GSK Investigational Site, La Laguna Santa Cruz

39008

GSK Investigational Site, Santander

45122

GSK Investigational Site, Essen

46202

GSK Investigational Site, Indianapolis

48013

GSK Investigational Site, Bilbao

53127

GSK Investigational Site, Bonn

55415

GSK Investigational Site, Minneapolis

60590

GSK Investigational Site, Frankfurt

60596

GSK Investigational Site, Frankfurt

68198

GSK Investigational Site, Omaha