201584 or FLAIR” is a study to compare two drugs (called Cabotegravir and Rilpivirine, as oral tablets followed by long-acting injections) to a single tablet regimen containing 3 HIV drugs (called Triumeq)
- 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
- EUCTR2016-001646-25-GB
- 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
- 566
Participants eligible for enrollment in the study must meet all of the following criteria:
AGE
1. HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent.
TYPE OF PARTICIPANT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
2. HIV-1 infection as documented by Screening plasma HIV-1 RNA =1000 c/mL;
3. Antiretroviral-naïve (=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary.
SEX
4. Female Participants:
A female participant is eligible to participate if she is not pregnant at Screening and first
day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test), 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) (see Appendix 7.) from 30 days prior to the first dose of study medication, throughout the study, and 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.
ALL participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.
INFORMED CONSENT
Capable of giving signed informed consent as described in Section 6.2 which includes compliance with the requirements and restrictions listed in the consent form and in this
protocol.
OTHER
French participants: In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 590
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
A participant will not be eligible for inclusion in this study if any of the following criteria
apply:
Exclusionary Medical Conditions
1. Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed
during the study.
2. Any evidence at Screening of an active Centers for Disease and Prevention Control
(CDC) Stage 3 disease [CDC, 2014], except cutaneous Kaposi’s sarcoma not requiring systemic therapy or historic or current CD4+ cell count <200 cells/mm3 are not exclusionary (local guidelines dictate).
3. Participants with known moderate to severe hepatic impairment.
4. Any pre-existing physical or mental condition (including substance abuse 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.
5. 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.
6. Participant who, in the investigator's judgment, poses a significant suicide risk. Participant’s recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.
7. The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions.
8. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti- HBc), Hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:
- Participants positive for HBsAg are excluded;
- Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg
status) and positive for HBV DNA are excluded.
Note: Participants positive for anti-HBc (negative HBsAg status) and positive for
anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.
9. Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor.
Participants with HCV co-infection will be allowed entry into Phase 3 studies if:
- Liver enzymes meet entry criteria.
- HCV Disease has undergone appropriate work-up, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment.
- In the event that recent biopsy or imaging data is not available or is inconclusive,
the Fib-4 score will be used to verify eligibility.
A Fib-4 score > 3.25 is exclusionary
Fib-4 scores 1.45 – 3.25 requires Medical Monitor consultation.
Fibrosis 4 Score Formula:
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