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Human Immunodeficiency VirusPhase 2CAPRISA014NCT02462772

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

A Phase 2 study testing cabotegravir in people with Human Immunodeficiency Virus, run by Centre for the AIDS Programme of Research in South Africa at 2 sites in South Africa.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
cabotegravir
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesSouth Africa
Study dates
Oct 2015to Sep 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able and willing to provide written informed consent to be screened for, and to enrol in, the study.
  • Able and willing to provide adequate locator information for study retention purposes.
  • Sexually active, defined as having had vaginal intercourse at least once in the past 30 days prior to screening.
  • HIV negative on testing performed by study staff
  • Have a negative pregnancy test performed by study staff
  • Agree to use a non-barrier form of contraceptive
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  • Agree to adhere to study visits and procedures.
  • Haemoglobin > 11 g/dL,
  • ALT < ULN
  • AST < ULN
  • Total bilirubin < Grade 1
  • Direct bilirubin < ULN
  • Creatinine clearance ≥60 mL/min
  • Hepatitis B surface antigen (HBsAg) negative
  • Hepatitis C Ab negative
  • In general good health, as assessed clinically

Who cannot join

  • Past or current participation in any other HIV interventional research study or other concurrent studies which may interfere with this study.
  • Clinically significant cardiovascular disease, including:
  • ECG with:
  • heart rate <50 or >100 beats per minute (one repeat ECG is allowed during screening; can be performed on the same day)
  • QRS duration >120 msec
  • QTc interval (B or F) > 450 msec
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  • evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)
  • any conduction abnormality (including but not specific to left or right complete bundle branch block, Atrioventricular block [2nd degree (type II) or higher], Wolf Parkinson White syndrome)
  • sinus pauses > 3 seconds
  • any significant arrhythmia which, in the opinion of the Principal Investigator or designee, will interfere with the safety for the individual participant
  • history of non-sustained (3 consecutive ventricular ectopic beats on ECG at screening or entry) or sustained ventricular tachycardia
  • History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease
  • Underlying skin disease or currently active skin disorder (e.g., infection, inflammation, dermatitis, eczema, psoriasis, urticaria). Mild cases of localized disease or other mild skin condition may not be exclusionary at the discretion of the Principal Investigator or designee.
  • Has a tattoo or other dermatological condition overlying the buttock region which in the opinion of the Principal Investigator or designee, may interfere with interpretation of injection site reactions.
  • History of acute or chronic liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy).
  • Coagulopathy (primary or iatrogenic) which would contraindicate IM injection.
  • Active or planned use of prohibited medications as described in the SSP manual (updated regularly from the Investigator's Brochure).
  • Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study.
  • Known Hypersensitivity to egg, soya or peanut protein.
  • Has any other condition that, based on the opinion of the Principal Investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • CAPRISA eThekwini Research Clinic

    Durban, KwaZulu-Natal, 4001

  • CAPRISA Vulindlela Research Clinic

    eMafakatini, KwaZulu-Natal, 3290

Other trials in South Africa

About this study

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

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.

Read the detailed description

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.

Being tested
cabotegravir, Placebo
Keywords
Cabotegravir, safety, long-acting injectable, HIV prevention, acceptability
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cabotegravirDrug

    Also called GSK1265744

    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.

  • PlaceboDrug

    Also called Intralipid® 20%

    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.

Study groups in NCT02462772
Study groupRoleWhat they receive
CabotegravirExperimentalWomen 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
Receives: Drug: cabotegravir
PlaceboPlacebo comparatorWomen 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    The incidence of increase in graded AEs and in particular liver enzymes (AST/ALT) at the level of Grade 3 or higher.

    Measured: 36 months

Secondary outcomes (6)

  1. Acceptability of study injections and oral tablets

    Participant's opinions on the injections and tablets will be obtained through structured interviews.

    Measured: 24 months

  2. Incidence of sexually transmitted infections

    Incidence of HIV, HSV-2, HPV, gonorrhoea, chlamydia and trichomonas infections in women

    Measured: 36 months

  3. Area under the plasma concentration versus time curve (AUC) of cabotegravir

    Cabotegravir concentrations will be measured throughout the study

    Measured: 36 months

  4. Impact on pregnancy

    The incidence of pregnancy and pregnancy outcomes in women assigned to cabotegravir and placebo will be compared

    Measured: 36 months

  5. Resistance to antiretroviral drugs

    Viruses from HIV seroconverters will be sequenced and assessed for resistance mutations

    Measured: 36 months

  6. HIV viral load in women who acquire HIV

    HIV viral load (copies/ml) will be measured and compared between the cabotegravir and placebo arms

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462772
Sponsor's protocol ID
CAPRISA 014
Acronym
CAPRISA014
Status last verified
Nov 2015
First submitted
27 May 2015
Last updated
5 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Radzio J, Spreen W, Yueh YL, Mitchell J, Jenkins L, Garcia-Lerma JG, Heneine W. The long-acting integrase inhibitor GSK744 protects macaques from repeated intravaginal SHIV challenge. Sci Transl Med. 2015 Jan 14;7(270):270ra5. doi: 10.1126/scitranslmed.3010297.

    PubMed 25589631

  • Spreen WR, Margolis DA, Pottage JC Jr. Long-acting injectable antiretrovirals for HIV treatment and prevention. Curr Opin HIV AIDS. 2013 Nov;8(6):565-71. doi: 10.1097/COH.0000000000000002.

    PubMed 24100877

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cabotegravir in people with Human Immunodeficiency Virus, run by Centre for the AIDS Programme of Research in South Africa at 2 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2015.

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