NCT03164564 - Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women | Biotech Hunter

Enrollment

3,224

Participants

Timeline

Start Date

November 7, 2017

Primary Completion Date

November 5, 2020

Study Completion Date

October 17, 2026

Conditions

HIV Infections

Interventions

DRUG

Oral CAB

CAB 30 mg tablet

DRUG

Oral TDF/FTC

TDF/FTC 300 mg/200 mg fixed dose combination tablet

DRUG

Placebo for oral CAB

Placebo tablets

DRUG

Placebo for oral TDF/FTC

Placebo tablets

DRUG

CAB LA

600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle

DRUG

Placebo for CAB LA

Administered as one 3 mL intramuscular injection in the gluteal muscle

Trial Locations (20)

1862

Soweto HPTN CRS, Johannesburg

2001

Ward 21 CRS, Johannesburg

3660

Botha's Hill CRS, Durban

4110

Isipingo CRS, Isipingo

4340

Verulam CRS, Verulam

7505

Desmond Tutu TB Centre - Stellenbosch University (DTTC-SU) CRS, Cape Town

7750

Emavundleni CRS, Cape Town

40100

Kisumu Crs, Kisumu

Unknown

Gaborone CRS, Gaborone

Eswatini Prevention Center CRS, Mbabane

Malawi CRS, Lilongwe

Blantyre CRS, Blantyre

UVRI-IAVI HIV Vaccine Program LTD. CRS, Entebbe

Baylor-Uganda CRS, Kampala

MU-JHU Research Collaboration (MUJHU CARE LTD) CRS, Kampala

Zengeza CRS, Chitungwiza

Seke South CRS, Chitungwiza

St Mary's CRS, Chitungwiza

Milton Park CRS, Harare

Spilhaus CRS, Harare

All Listed Sponsors

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH