Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2015

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Human Immunodeficiency Virus
Interventions
DRUG

cabotegravir

Cabotegravir 30 mg tablets are formulated as white to almost white oval-shaped coated tablets for oral administration. The cabotegravir LA is formulated as a sterile white to slightly coloured suspension containing 400mg/2mL of cabotegravir LA for administration by IM injection.

DRUG

Placebo

Placebo tablets for cabotegravir are formulated as white to almost white oval-shaped coated tablets to visually match the active cabotegravir tablets. Placebo for cabotegravir injectable suspension is Intralipid® 20%. Intralipid® is a fat emulsion with no pharmacological action. It is a white, milky emulsion, consisting of purified soyabean oil, purified egg phospholipids and anhydrous glycerol. Intralipid® 20% is supplied in infusion bags.

Trial Locations (2)

3290

CAPRISA Vulindlela Research Clinic, eMafakatini

4001

CAPRISA eThekwini Research Clinic, Durban

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

lead

Centre for the AIDS Programme of Research in South Africa

NETWORK