Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa (CAPRISA014)
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|ClinicalTrials.gov Identifier: NCT02462772|
Recruitment Status : Withdrawn
First Posted : June 4, 2015
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: cabotegravir Drug: Placebo||Phase 2|
The CAPRISA 014 trial is designed to establish the safety and acceptability of cabotegravir LA in sexually active, at-risk HIV-uninfected women. A total of 632 HIV uninfected women (18 to 30 years) from two sites in KwaZulu-Natal, South Africa will be enrolled. The trial will be approximately 24 months, with an additional 12 months post-trial safety observation. The study is divided into three periods:
Period 1 - Clinical trial oral lead-in (up to 34 days) - Consenting participants will be randomized to receive daily oral cabotegravir (30mg tablets) or daily oral placebo for approximately 30 days, to assess safety and tolerability prior to exposure to the LA injectable formulation.
Period 2 - Clinical trial follow-up with injectable (approximately 48-96 weeks) - Participants who have successfully completed Period 1 will receive intra-muscular (IM) gluteal injections of cabotegravir LA (800 mg, administered as two 400 mg injections) or placebo every 12 weeks. The end of Period 2 marks the completion of clinical trial follow-up.
Period 3 - Post-trial safety follow-up off-product (approximately 12 months) - During this post-trial safety observation period, participants will be followed up (off product) for approximately 12 months after completion of period 2.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Trial to Assess the Safety and Acceptability of the Long-acting Injectable HIV Integrase Inhibitor, Cabotegravir (GSK1265744), in HIV Uninfected Women in KwaZulu-Natal, South Africa|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Women randomised to the cabotegravir arm will receive daily oral cabotegravir (30 mg tablets) for approximately 30 days and thereafter will receive intra-muscular gluteal injections of cabotegravir LA (800 mg, administered as two 400 mg injections) every 12 weeks
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.
Other Name: GSK1265744
Placebo Comparator: Placebo
Women randomised to the placebo arm will receive daily oral tablets (30 mg tablets) for approximately 30 days and thereafter will receive intra-muscular gluteal injections of Intralipid® 20% every 12 weeks
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.
Other Name: Intralipid® 20%
- Number of participants with adverse events [ Time Frame: 36 months ]The incidence of increase in graded AEs and in particular liver enzymes (AST/ALT) at the level of Grade 3 or higher.
- Acceptability of study injections and oral tablets [ Time Frame: 24 months ]Participant's opinions on the injections and tablets will be obtained through structured interviews.
- Incidence of sexually transmitted infections [ Time Frame: 36 months ]Incidence of HIV, HSV-2, HPV, gonorrhoea, chlamydia and trichomonas infections in women
- Area under the plasma concentration versus time curve (AUC) of cabotegravir [ Time Frame: 36 months ]Cabotegravir concentrations will be measured throughout the study
- Impact on pregnancy [ Time Frame: 36 months ]The incidence of pregnancy and pregnancy outcomes in women assigned to cabotegravir and placebo will be compared
- Resistance to antiretroviral drugs [ Time Frame: 36 months ]Viruses from HIV seroconverters will be sequenced and assessed for resistance mutations
- HIV viral load in women who acquire HIV [ Time Frame: 36 months ]HIV viral load (copies/ml) will be measured and compared between the cabotegravir and placebo arms
- Pharmacogenomics of cabotegravir [ Time Frame: 36 months ]The impact of genetic polymorphisms on response to cabotagravir LA will be assessed
- Impact of contraception on area under the plasma concentration versus time curve (AUC) of cabotegravir [ Time Frame: 36 months ]Cabotegravir concentrations in women on DMPA will be compared to women on other forms of contraception
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462772
|CAPRISA eThekwini Research Clinic|
|Durban, KwaZulu-Natal, South Africa, 4001|
|CAPRISA Vulindlela Research Clinic|
|Mafakatini, KwaZulu-Natal, South Africa, 3290|
|Principal Investigator:||Salim S Abdool Karim, MBCHB, PhD||Centre for the AIDS Programme of Research in South Africa|
|Principal Investigator:||Quarraisha Abdool Karim, PhD||Centre for the AIDS Programme of Research in South Africa|
|Principal Investigator:||Leila E Mansoor, PhD||Centre for the AIDS Programme of Research in South Africa|