HIV infection MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Symtuza
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DARUNAVIR
CAS Number: 206361-99-1
Other descriptive name: DARUNAVIR
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Spanish HIV/AIDS Research Networkº
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 2) Age = 18 years 3) Antiretroviral treatment naïve (= 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening. 4) Plasma HIV-1 RNA levels ? 500 copies/mL at screening. 5) Adequate renal function: Estimated glomerular filtration rate = 50 mL/min (= 0.83 mL/sec) according to the Cockcroft-Gault formula. 6) Hepatic transaminases (AST and ALT) ?5 x upper limit of normal (ULN). 7) Total bilirubin ?1.5 mg/dL (?26 umol/L), or normal direct bilirubin. 8) Adequate hematologic function (absolute neutrophil count = 750/mm3 (= 0.75 GI/L), platelets = 50,000/mm3 (= 50 GI/L); hemoglobin = 8.5 g/dL (= 85 g/L). 9) Serum amylase = 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is = 5 × ULN) 10) Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-sexually active from screening, throughout the duration of the study period, and for 30 days following the last dose of study drug. 11) Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception throughout the study period and for 90 days following the last dose of study drug. 12) Life expectancy = 1 year 13) Negative screening test for HLA-B*5701 allele from a local laboratory. 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 316 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening. 2) Subjects experiencing decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding). 3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g, corticosteroids, immunoglobulins, and other immune- or cytokinebased therapies). 4) A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. 5) Any anticipated to require systemic therapy during the study. 6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1. 7) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial. 8) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements. 9) Any known allergies to the excipients of D/C/F/TAF FDC or ABC/DTG/3TC FDC tablets. 10) Females who are pregnant (as confirmed by positive serum pregnancy test at screening). 11) Females who are breastfeeding. 12) Subjects receiving ongoing therapy with any significant interaction with the study drugs, including drugs not to be used with FTC, TAF, D, C DTG, ABC and 3TC. 13) Chronic Hepatitis B Virus (HBV) infection. 14) Active tuberculosis infection.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The change from baseline in log10 HIV-1 RNA and in CD4+ cell count at Week 48. • Viral loads < 400 and < 40 copies/mL at 24 weeks • Adverse events and clinical laboratory tests to evaluate the safety and tolerability of the treatment regimens.;Timepoint(s) of evaluation of this end point: For Adverse events and clinical laboratory tests to evaluate the safety and tolerability of the treatment regimens and The change from baseline in log10 HIV-1 RNA and in CD4+ cell count secondaries endpoints 48 week. For Viral loads < 400 and < 40 copies/mL 24 weeks | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of two fixed dose combinations (FDC) containing Darunavir 800 mg, Cobicistat 150 mg, Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (Symtuza®) versus Dolutegravir 50 mg, abacavir 600 mg and lamivudine 300 mg (Triumeq®) in HIV-1 infected, antiretroviral naïve adult subjects as determined by the achievement of HIV-1 RNA <50 copies/mL at Week 48.;Secondary Objective: To evaluate the efficacy, safety and tolerability of the two treatment groups through Weeks 12, 24 and 48.;Primary end point(s): The proportion of subjects who achieve HIV-1 RNA < 50 copies/mL at Week 48 as defined by the United States (US). Food and Drug Administration (FDA)-defined snapshot algorithm;Timepoint(s) of evaluation of this end point: For the primary end point the timepoint is 48 week | — |
Countries
Spain
Contacts
Public ContactUnidad de VIH y ETS
Hospital Universitari de Bellvitge
Outcome results
None listed