Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every 8 weeks in Virologically Suppressed HIV-1-infected Adults.
- Conditions
- Human Immunodeficiency Virus type 1 (HIV-1)MedDRA version: 20.1Level: LLTClassification code 10003582Term: Asymptomatic human immunodeficiency virus type I infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2017-002946-62-SE
- Lead Sponsor
- ViiV Healthcare UK Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1049
1. Aged 18 years or older (or =19 where required by local regulatory agencies), at
the time of signing the informed consent.
2. A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at screen and a negative urine hCG test at Randomization), not lactating, and at least one of the following conditions applies:
a. Non-reproductive potential defined as:
- Pre-menopausal females with one of the following:
Documented tubal ligation Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion
-Hysterectomy
-Documented Bilateral Oophorectomy
-Postmenopausal defined as 12 months of spontaneous amenorrhea [in
questionable cases a blood sample with simultaneous follicle stimulating
hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)]. Females on
hormone replacement therapy (HRT) and whose menopausal status is in
doubt will be required to use one of the highly effective contraception
methods if they wish to continue their HRT during the study. Otherwise,
they must discontinue HRT to allow confirmation of post-menopausal
status prior to study enrolment.
b. Reproductive potential and agrees to follow one of the options listed in the
Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of
Reproductive Potential (FRP) from 30 days prior to the first dose of study
medication, throughout the study, for at least 30 days after discontinuation of all
oral study medications, and for at least 52 weeks after discontinuation of CAB LA
and RPV LA.
The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Eligible participants or their legal guardians (and next of kin when locally
required), must sign a written Informed Consent Form before any protocol specified assessments are conducted. Enrolment of participants who are unable to provide direct informed consent is optional and will be based on local
legal/regulatory requirements and site feasibility to conduct protocol procedures.
4. Participants enrolled in France must be affiliated to, or a beneficiary of, a social
security category.
5. Must be on uninterrupted current regimen (either the initial or second ARV
regimen) for at least 6 months prior to Screening. Any prior switch, defined as a
change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for treatment failure (HIV-1 RNA =400 c/mL).
Acceptable stable (initial or second) ARV regimens prior to Screening include 2
NRTIs plus:
INI (either the initial or second cART regimen)
NNRTI (either the initial or second cART regimen)
Boosted PI (or atazanavir [ATV] unboosted) (must be either the initial cART regimen or one historical within class switch is permitted due to safety/tolerability)
The addition, removal, or switch of a drug(s) that has been used to treat HIV
based on antiretroviral properties of the drug constitutes a change in ART with the following limited exceptions:
Historical changes in formulations of ART drugs or booster drugs will not
constitute a chang
1. Within 6 months prior to Screening, any plasma HIV-1 RNA measurement = 50 c/mL
2. Within the 6 to 12-month window prior to Screening, any plasma HIV-1 RNA
measurement >200 c/mL, or 2 or more plasma HIV-1 RNA measurements = 50 c/mL
3. Any drug holiday during the window between initiating first HIV ART and 6
months prior to Screening, except for brief periods (less than 1 month) where all
ART was stopped due to tolerability and/or safety concerns
4. Any switch to a second line regimen, defined as change of a single drug or
multiple drugs simultaneously, due to virologic failure to therapy (defined as a
confirmed plasma HIV-1 RNA measurement =200 c/mL after initial suppression
to <50 c/mL while on first line HIV therapy regimen)
5. A history of use of any regimen consisting of only mono or dual HIV-1 therapy
(even if only for peri-partum treatment).
6.Participants who are currently
participating in or anticipate to be selected for any other interventional study with the exception of the 201585 (ATLAS) study.
7. During participation in ATLAS, consecutive (2 or more sequential) plasma HIV-1
RNA measurements = 50 c/mL
8. During participation in ATLAS, any HIV-1 RNA measurement = 200 c/mL
9. More than two total measurements of plasma HIV-1 RNA = 50 c/mL during
participation in the ATLAS trial will require direct approval by the ATLAS-2M
Medical Monitor and Study virologist for study participation.
10. Women who are pregnant, breastfeeding or plan to become pregnant or breastfeed during the study
11. Any evidence of a current Center for Disease Control and Prevention (CDC)
Stage 3 disease [CDC, 2014] , except cutaneous Kaposi’s sarcoma not requiring
systemic therapy, and CD4+ counts <200 cells/µL are not exclusionary.
12. Participants with moderate to severe hepatic impairment
13. Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant’s ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant
14. Participants determined by the Investigator to have a high risk of seizures,
including participants with an unstable or poorly controlled seizure disorder. A
participant with a prior history of seizure may be considered for enrolment if the
Investigator believes the risk of seizure recurrence is low. All cases of prior
seizure history should be discussed with the Medical Monitor prior to enrolment
15. All participants will be screened for syphilis. Participants with untreated secondary (late latent) or tertiary syphilis infection,
defined as a positive RPR and a positive treponemal test without clear
documentation of treatment, are excluded. Participants with a false positive RPR
(with negative treponemal test) or serofast RPR result (persistence of a reactive
nontreponemal syphilis test despite history of adequate therapy and no evidence
of re-exposure) may enroll after consultation with the Medical Monitor.
Participants with primary syphilis or early latent secondary syphilis (acquired
within the preceding year) who have a positive RPR test and have not been treated may be treated during the screening period and if completion of antibiotic treatment occurs during the screening period, may be allowed entry after consultation with the Medical Monitor. If antibiotic treatment cannot be
completed before the screening window ends, subjects may be rescreened once
following completi
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method