Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC (STRUCTR)

Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching From EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)

Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)

Study Overview

• Status: Unknown
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: Triumeq

Detailed Description

Phase IV, Single-Arm, Open-Label Study Evaluating Bone Mineral Density in HIV-1-Infected Adults ≥50 Years Old Switching from EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild) to ABC/DTG/3TC (Triumeq)

To evaluate the impact on BMD, as measured by DEXA over 48 weeks, of switching from an INSTI-based regimen with either TDF or TAF to a regimen of ABC/DTG/3TC (administered as commercial Triumeq) in chronic HIV-infected patients over the age of 50

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Recruiting
      • Mills Clinical Research
      • Contact: Ron Knight; Phone Number: 310-550-2271; Email: ron.knight@millsclinicalresearch.com
      • Contact: Jake Collins; Phone Number: 310-550-2271; Email: jake.collins@millsclinicalresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Documented HIV-1 infection;
2. At least 50 years of age;
3. Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);

4. HIV is currently suppressed, defined as:

   1. Plasma HIV-1 RNA <50 c/mL for ≥3 months preceding Screening; AND
   2. Plasma HIV-1 RNA <50 copies/mL at the Screening assessment; INCL 5. Documentation that the participant is negative for the human leukocyte antigen (HLA)-B*5701 allele.

Exclusion Criteria:

1. Pregnant, breastfeeding, or planning to become pregnant during the study period;
2. Bilateral hip replacement;
3. Exceeds weight limit for DEXA equipment (i.e., weighs >350 lbs or >159 kg);
4. History or presence of allergy to the study treatment (Triumeq) or any of its components (to ABC, DTG, or 3TC);
5. Active Centers for Disease Control and Prevention (CDC) Category C HIV-1 disease (see Section 17.1 for definition), with the exception of cutaneous Kaposi's sarcoma, not requiring systemic therapy and historic CD4+ cell counts of <200 cells/mm3;
6. Positive for hepatitis B virus surface antigen (HBsAg) at Screening;
7. Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);
8. Significant suicidal risk in the investigator's opinion;
9. Metabolic disease;
10. Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;
11. Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune responses) within 28 days of Screening;
12. Exposure to any experimental drug or vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to first dose of study treatment on Day 1;
13. History of use of only mono or dual NRTI therapy prior to starting combination ART for the treatment of HIV infection (except that prior NRTI use for the purpose of pre-exposure prophylaxis [PrEP] or postexposure prophylaxis [PEP] is not excluded);
14. Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP or PEP;

15. Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:

    1. Historical genotype in the participant's medical record; OR
    2. Genotype obtained by GenoSure Archive evaluation at Screening;
16. Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
17. Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;

18. Either of the following liver chemistry elevations:

    1. Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR
    2. ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with >35% direct bilirubin);
19. Creatinine clearance (CrCl) of <50 mL/min (calculated by CockroftGault equation)
20. QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
21. Any other condition or substance use that in the opinion of the investigator places the participants at undue risk from participation in the study or that may negatively impact the integrity of the study analyses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triumeq; Single Arm, Open Label	Drug: Triumeq; Open Label, Switch to Triumeq (ABC/DTG/3TC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)	48 Weeks
Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)	48 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC		96 Weeks
Change from baseline in bone mineral density (in lumbar spine and total hip) assessed by T-scores and Z-scores from Baseline in individuals switching to ABC/DTG/3TC	Z-score = (Patient's BMD - expected BMD) / SD; T-score = (BMD-Reference BMD)/SD Units are numerical in value. BMD)/SD Units are numerical in value.	96 Weeks
Number of adverse events (including long-term virologic/immunologic responses, abnormal laboratory values, or untoward medical conditions) for individuals switching to ABC/DTG/3TC		96 Weeks

Collaborators and Investigators

• Sponsor: Mills Clinical Research
• Collaborators: ViiV Healthcare
• Investigators: Principal Investigator: Anthony M Mills, MD, Mills Clinical Research

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Triumeq
• Other Study ID Numbers: 205773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES