Dual Therapy With Boosted Darunavir + Dolutegravir

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

A switch strategy to investigate whether a dual therapy with Ritonavir-boosted (RTV) Darunavir (DRV) + Dolutegravir (DTG) over 48 weeks is non-inferior to a continuous standard of care therapy with RTV-boosted DRV in combination with 2 Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) in HIV patients, who are on a stable antiretroviral therapy (ART) with RTV-boosted DRV in combination with 2 NRTIs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Technische Universität München
• Treatments: Abacavir; Darunavir; Dolutegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• HIV-1 infection with HIV-1 RNA < 50 cps/ml at screening and within a period of 24 weeks prior to screening with one accepted blip of HIV-1 RNA < 200 cps/ml and well-tolerated antiretroviral therapy of 2 NRTI in combination with DRV/r.

• No known genotypic DRV- or integrase inhibitor-related HIV resistance

• Signed written informed consent

• Documented negative HLA B*57:01 (only in case of Abacavir-containing ART)

• A female subject may be eligible to enter and participate in the study if she:

• is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or

• is of child-bearing potential with a negative pregnancy test at both screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:

• Complete abstinence from penile-vaginal intercourse from 2 weeks prior to administration of IMP, throughout the study, and for at least 2 weeks after discontinuation of all study medications

• Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)

• Male partner sterilization confirmed prior to the female subject's entry into the study, and this male is the sole partner for that subject

• Approved hormonal contraception without DRV/r interactions and a barrier method

• Any other method with published data showing that the expected failure rate is <1% per year. Any contraception method must be used consistently, in accordance with the approved product label and for at least 2 weeks after discontinuation of IMP.

Exclusion Criteria:

• Pregnant women and nursing mothers

• Chronic HBV infection (HBsAg and/or HBV DNA positive)

• Any evidence of a Center for Disease Control and Prevention (CDC) Category C disease at screening, except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts < 200 cells/mm3 or historic CDC C diseases are not exclusionary

• History or presence of allergy to the study drugs or their components

• Subject has creatinine clearance of <50 mL/min by MDRD eGFR calculation

• Alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), OR ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)

• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

• Subjects with severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification

• Anticipated need for interferon-based Hepatitis C virus (HCV) therapy during the study

• Participation in other interventional clinical trials at the same time

• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

• Persons held in an institution by legal or official order

• Imprisoned people, people requiring in-house treatment for psychiatric disorders or people who are unable to give informed consent