Dual Therapy With Boosted Darunavir + Dolutegravir

NCT02486133 | Completed Phase 3 DMC

• 1 other identifier: DUA-1463-SPI-0320-I
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-Infection

Outcome Measures

Primary Outcomes (1)

• number (%) of patients with fully suppressed HIV RNA < 50 cps/ml at week 48

  For primary endpoint, HIV RNA suppression \< 50 cps/ml will be assessed at week 48, using NAT diagnostic.

  48 weeks

Study Arms (2)

A: boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR)

EXPERIMENTAL

Prezista \& Norvir \& Tivicay

Drug: Prezista; Drug: Norvir; Drug: Tivicay

B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

ACTIVE COMPARATOR

Prezista \& Norvir \& Truvada or Prezista \& Norvir \& Kivexa or Prezista \& Norvir \& Descovy

Drug: Prezista; Drug: Norvir; Drug: Truvada; Drug: Kivexa; Drug: Descovy

Interventions

Prezista DRUG

once daily

Also known as: Darunavir

A: boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR); B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

Norvir DRUG

once daily

Also known as: Ritonavir

A: boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR); B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

Tivicay DRUG

once daily

Also known as: Dolutegravir

A: boosted darunavir (bDRV) plus dolutegravir (DTG; 2DR)

Truvada DRUG

once daily

Also known as: Tenofovir disaproxil fumarat/emtricitabine

B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

Kivexa DRUG

once daily

Also known as: Abacavir/Lamivudine

B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

Descovy DRUG

once daily

Also known as: Tenofovir alafenamid / emtricitabine

B: bDRV plus 2 nucleoside reverse-transcriptase inhibitors (NRTIs; 3DR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• HIV infection with HIV RNA \< 50 cps/ml within a period of at least 24 weeks suppressive ART prior to randomization, with one accepted blip of HIV RNA \< 200 cps/ml and well-tolerated antiretroviral therapy: consisting of 2 NRTI (ABC/3TC, F/TDF or F/TAF) in combination with DRV/r for a period of at least 28 days prior to randomizsation.
• 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.

You may not qualify if:

• Pregnant women and nursing mothers
• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

Munich, 81675, Germany

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Darunavir; Ritonavir; dolutegravir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; abacavir, lamivudine drug combination; emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Sulfones; Sulfur Compounds; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Tenofovir; Organophosphonates; Organophosphorus Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Christoph Spinner, MD

  Dep. of Medicine II & IZAR, Klinikum rechts der Isar der TUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: July 1, 2015
• Study Start: July 1, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: November 29, 2023

Record last verified: 2019-04

Locations

DE (1)