switch study to evaluate the safety and efficacy of emtricitabine/rilpivirine/tenofovir alafenamide (ftc/rpv/taf) fixed dose combination (fdc) in hiv-1 positive adults who are virologically suppressed on emtricitabine/rilpivirine/tenofovir disoproxil fumarate (ftc/rpv/tdf)

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (ftc/rpv/taf) fixed-dose combination (fdc) as compared to continuing ftc/rpv/tenofovir disoproxil fumarate (tdf) fdc (ftc/rpv/tdf) in virologically suppressed hiv-1 infected participants.


Eligibility criteria:
key inclusion criteria: * the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * currently receiving ftc/rpv/tdf fdc for ≥ 6 consecutive months preceding the screening visit * documented plasma hiv-1 rna levels \ 50 copies/ml) for ≥ 6 months preceding the screening visit. after reaching hiv-1 rna \< 50 copies/ml, single values of hiv-1 rna ≥ 50 copies/ml followed by resuppression, are allowed * have no documented resistance to any of the study agents at any time in the past * hiv-1 rna \< 50 copies/ml at the screening visit * hepatic transaminases (ast and alt) ≤ 5 × upper limit of normal (uln) * total bilirubin ≤ 1.5 mg/dl (≤ 26 μmol/l), or normal direct bilirubin * adequate hematologic function (absolute neutrophil count ≥ 1,000/mm\^3 (1.00 gi/l); platelets ≥ 50,000/mm\^3 (50 gi/l); hemoglobin ≥ 8.5 g/dl (85 g/l)) * serum amylase ≤ 5 × uln (individuals with serum amylase \> 5 × uln will remain eligible if serum lipase is ≤ 5 × uln) * normal ecg (or if abnormal, determined by the investigator to be not clinically significant) * adequate renal function: estimated glomerular filtration rate ≥ 50 ml/min (1.17 ml/sec) according to the cockcroft-gault formula key exclusion criteria: * hepatitis b surface antigen (hbsag) positive * hepatitis c antibody positive with detectable hepatitis c virus (hcv) rna (individuals who have hcv antibody but no detectable hcv rna are eligible to enroll) * individuals experiencing or with a medical history of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.) * females who are breastfeeding * positive serum pregnancy test * current alcohol or substance use judged by the investigator to potentially interfere with individual's study compliance * a history of malignancy within the past 5 years (prior to screening) or ongoing malignancy other than cutaneous kaposi's sarcoma (ks), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. individuals with cutaneous ks are eligible, but must not have received any systemic therapy for ks within 30 days of baseline/day 1 and must not be anticipated to require systemic therapy during the study * active, serious infections (other than hiv-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline/day 1 * any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements * participation in any other clinical trial (including observational trials) without prior approval from the sponsor is prohibited while participating in this trial * individuals receiving ongoing therapy with any of the disallowed medications listed in the protocol, including drugs not to be used with ftc, rpv and/or taf; or individuals with any known allergies to the excipients of ftc/rpv/taf note: other inclusion/exclusion criteria may apply.

Keywords: hiv