A Phase III, Randomized, Multicenter, Parallel-group, Open-Label Study Evaluating the Efficacy, Safety, and Tolerability of Long-Acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch from an Integrase Inhibitor Single Tablet Regimen in HIV-1 Infected Antiretroviral Therapy Naive Adult Participants (study 201584, FLAIR)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

* HIV-1 infected, ART-naive men or women aged 18 years or older.
* HIV-1 infection as documented by Screening plasma HIV-1 RNA *1000 c/mL.
* 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 NNRTI will be exclusionary.

Exclusion Criteria

* Women who are pregnant, breastfeeding, or plan to become pregnant or
breastfeed during the study.
* All active CDC stage 3 diseases at screen are exclusionary, except cutaneous
Kaposi*s sarcoma (not requiring systemic therapy) or historic or current CD4+
cell count <200 cells/mm3.
* Known moderate to severe hepatic impairment.
* High risk of seizures, see protocol page 70 for details.
* Significant suicide risk, see protocol page 70-71 for details.
* Evidence of Hepatitis B virus, see protocol page 71 for details.
* Asymptomatic individuals with chronic hepatitis C virus infection will not be
excluded, see protocol page 71 for details.
* Untreated syphilis infection, see protocol page 72 for details.
* Clinically significant cardiovascular disease, see protocol page 72 for
details.
* Concomitant medications, see protocol page 72 for details.
* Any evidence of primary resistance to NNRTIs, see protocol page 73 for
details.
* HLA-B*5701 positive and are unable to use an NRTI backbone that does not
contain abacavir, see protocol page 73 for details.
* Any verified Grade 4 laboratory abnormality.
* Estimated creatinine clearance <50 mL/min/1.73m2.
* Currently participating in or anticipating to be selected for any other
interventional study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of participants with a virologic failure endpoint (see protocol<br /><br>page 28-29 for details) at Week 48.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Proportion of participants with plasma HIV-1 RNA <50/200 c/mL at week 48/96,<br /><br>virologic failure at week (48-)96. Absolute values and change from baseline in<br /><br>plasma HIV-1 RNA at week 48/96. Absolute values and changes from Baseline in<br /><br>CD4+ cell counts over time. Incidence of disease progression. Adverse events.<br /><br>Lipids. Incidence of treatment emergent genotypic and phenotypic resistance to<br /><br>CAB, RPV, and other on-study ART at Week 48/96. PK parameters. Outcomes<br /><br>questionnaires (HAT-QoL, treatment satisfaction score, SF-12, ACCEPT, Numeric<br /><br>Rating Scale injection tolerability).</p><br>

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Recruitment & Eligibility

Study & Design

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