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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2017 by Anthony Mills MD, Mills Clinical Research

Sponsor
Mills Clinical Research

Collaborator
ViiV Healthcare

Information provided by (Responsible Party)
Anthony Mills MD, Mills Clinical Research

ClinicalTrials.gov Identifier
NCT03275701

First received: July 22, 2016
Last updated: September 5, 2017
Last Verified: September 2017
History of Changes
Purpose

Purpose

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)

Condition Intervention
Infection, Human Immunodeficiency Virus

Drug : Triumeq

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by Anthony Mills MD, Mills Clinical Research:

Primary Outcome Measures

  • Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA) [ Time Frame: 48 Weeks ]
  • Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA) [ Time Frame: 48 Weeks ]
Other Outcome Measures:
  • Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC [ Time Frame: 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 [ Time Frame: 96 Weeks ]
    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.
  • Number of adverse events (including long-term virologic/immunologic responses, abnormal laboratory values, or untoward medical conditions) for individuals switching to ABC/DTG/3TC [ Time Frame: 96 Weeks ]

Estimated Enrollment: 50
Study Start Date: July 2016
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Triumeq
Single Arm, Open Label
Drug: Triumeq

Open Label, Switch to Triumeq (ABC/DTG/3TC)

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

Eligibility

Eligibility

Ages Eligible for Study: 50 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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;
          1. Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
          2. Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
          3. 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);
            1. Creatinine clearance (CrCl) of <50 mL/min (calculated by CockroftGault equation)
            2. QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
            3. 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.

          contacts and locations

          Contacts and Locations

          Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

          Please refer to this study by its ClinicalTrials.gov identifier: NCT03275701

          Contacts

          Contact:   Anthony Mills, MD 310-550-2271 tony.mills@millsclinicalresearch.com
          Contact:   Ron Knight 310-550-2271 ron.knight@millsclinicalresearch.com

          Locations

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

          Sponsors and Collaborators

          Mills Clinical Research
          ViiV Healthcare

          Investigators

          Principal Investigator: Anthony M Mills, MD Mills Clinical Research
          More Information

          More Information


          Responsible Party: Anthony Mills MD, Clinical Research Director, Mills Clinical Research  
          ClinicalTrials.gov Identifier: NCT03275701   History of Changes  
          Other Study ID Numbers: 205773  
          Study First Received: July 22, 2016  
          Last Updated: September 5, 2017  

          Additional relevant MeSH terms:
          Immunologic Deficiency Syndromes
          Acquired Immunodeficiency Syndrome
          HIV Infections

          ClinicalTrials.gov processed this data on October 20, 2017
          This information is provided by ClinicalTrials.gov.