Evaluation of Switching From Current cART to Triumeq With Adherence Support Will Enhance HIV Control in Vulnerable Populations

NCT02354053 | Completed Phase 4 DMC

• 1 other identifier: CTN286
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Modern antiretroviral therapeutic regimens offer a vast array of choice that permits tailored therapy for HIV patients. While modern regimens have improved the rates of virologic suppression overall and reduced adverse effects of antiretroviral treatment, an important sub-group of HIV infected persons is unable to maintain adherence to their treatment regimens, fail to achieve long term virologic control and remain at risk for HIV related disease progression and transmission of HIV infection. Hypothesis: switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART as determined by the achievement of HIV-1 RNA \< 50 copies/mL at Week 24 post randomization.

Conditions

HIV Infections

Keywords

HIV; Triumeq; vulnerable populations

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy of the Switch from ART to Triumeq with adherence support as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24 post randomization.

  To determine if switching from current cART regimen to a Triumeq based regimen combined with adherence support will improve the rate of HIV suppression in vulnerable populations non-adherent to the their current cART.

  24 weeks

Secondary Outcomes (2)

• Improve of average adherence

  24 weeks

• Maintaining Adherence over the time

  72 weeks

Study Arms (2)

Current ART

ACTIVE COMPARATOR

Current ART + adherence support

Behavioral: Adherence support + current ART

Triumeq

EXPERIMENTAL

Triumeq + adherence support

Drug: Switch to Triumeq; Behavioral: Adherence support + current ART

Interventions

Switch to Triumeq DRUG

Triumeq

Adherence support + current ART BEHAVIORAL

Current ART; Triumeq

Eligibility Criteria

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

You may qualify if:

• HIV-1 infected adults greater than or equal to 18 years of age.
• Prescribed cART that may include any DHHS recommended or alternative regimens, which the treating physician considers, is appropriate for their patient with the exception of dolutegravir
• Evidence of non-adherence to current ART regimen defined as:
• HIV RNA ≥400 copies/ml at least once in last 12 months
• Absence of resistance to current regimen
• Viremia not explained by normal viral decay after initiating ART
• Documentation that the subject is negative for HLA-B\*5701 allele
• Signed informed consent prior to screening.
• Women who are suspected, planning to become or pregnant or breastfeeding must have a negative pregnancy test at screening and Day 1 and agree to use the following approved methods of birth control while on study.
• A female, 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 IP, 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);
• Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion

You may not qualify if:

• Women who are pregnant or breastfeeding
• Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease25 except cutaneous Kaposi's sarcoma not requiring systemic therapy
• Subjects with moderate to severe hepatic impairment (Class B or C) as determined by Child-Pugh classification
• Anticipated need for Hepatitis C virus (HCV) therapy during the study
• Chronic hepatitis B infection (defined as HBsAg positive)
• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class
• Any evidence of viral resistance to 3TC, abacavir or integrase inhibitors or to any component of the current regimen based on the presence of primary resistance-associated mutations for these drugs26 on any available historical resistance test.
• Any evidence of viral resistance to 3TC, abacavir or integrase inhibitors or to any component of the current regimen based on the presence of primary resistance-associated mutations for these drugs26 on a screening genotype for patients with HIV RNA ≥400 copies/ml .
• Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study
• Alanine aminotransferase (ALT) greater than 5 times the upper limit of normal, OR ALT greater than or equal to3 times the upper limit of normal and bilirubin greater than or equal to1.5 times the upper limit of normal (with greater than 35% direct bilirubin)
• Creatinine clearance of less than 50 mL/min via Cockroft-Gault method
• Concomitant medications, dofetilide and immunosuppressants.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• ViiV Healthcare: collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

Chronic Viral Illness Service

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Marina Klein, MD

  Chronic Viral Illness Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 3, 2015
• Study Start: November 1, 2015
• Primary Completion: July 3, 2018
• Study Completion: July 2, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

CA (1)