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

NCT02462772 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-11-05

No results posted yet for this study

Summary

The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA) injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in KwaZulu-Natal, South Africa.

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.

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Centre for the AIDS Programme of Research in South Africa

    lead NETWORK

Principal Investigators

  • Salim S Abdool Karim, MBCHB, PhD · Centre for the AIDS Programme of Research in South Africa

  • Quarraisha Abdool Karim, PhD · Centre for the AIDS Programme of Research in South Africa

  • Leila E Mansoor, PhD · Centre for the AIDS Programme of Research in South Africa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • South Africa

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462772 on ClinicalTrials.gov