Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC (STRUCTR)
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triumeq
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- Documented HIV-1 infection;
- At least 50 years of age;
- Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);
HIV is currently suppressed, defined as:
- Plasma HIV-1 RNA <50 c/mL for ≥3 months preceding Screening; AND
- 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:
- Pregnant, breastfeeding, or planning to become pregnant during the study period;
- Bilateral hip replacement;
- Exceeds weight limit for DEXA equipment (i.e., weighs >350 lbs or >159 kg);
- History or presence of allergy to the study treatment (Triumeq) or any of its components (to ABC, DTG, or 3TC);
- 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;
- Positive for hepatitis B virus surface antigen (HBsAg) at Screening;
- Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);
- Significant suicidal risk in the investigator's opinion;
- Metabolic disease;
- Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;
- Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune responses) within 28 days of Screening;
- 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;
- 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);
- Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP or PEP;
Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:
- Historical genotype in the participant's medical record; OR
- Genotype obtained by GenoSure Archive evaluation at Screening;
- Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
- Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
Either of the following liver chemistry elevations:
- Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR
- ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with >35% direct bilirubin);
- Creatinine clearance (CrCl) of <50 mL/min (calculated by CockroftGault equation)
- QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
- 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.
Sites / Locations
- Mills Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Triumeq
Arm Description
Single Arm, Open Label
Outcomes
Primary Outcome Measures
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)
Secondary Outcome Measures
Full Information
NCT ID
NCT03275701
First Posted
July 22, 2016
Last Updated
September 5, 2017
Sponsor
Mills Clinical Research
Collaborators
ViiV Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03275701
Brief Title
Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC
Acronym
STRUCTR
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mills Clinical Research
Collaborators
ViiV Healthcare
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triumeq
Arm Type
Other
Arm Description
Single Arm, Open Label
Intervention Type
Drug
Intervention Name(s)
Triumeq
Intervention Description
Open Label, Switch to Triumeq (ABC/DTG/3TC)
Primary Outcome Measure Information:
Title
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
Time Frame
48 Weeks
Title
Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)
Time Frame
48 Weeks
Other Pre-specified Outcome Measures:
Title
Change from Baseline in bone biomarkers for individuals switching to ABC/DTG/3TC
Time Frame
96 Weeks
Title
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
Description
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.
Time Frame
96 Weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented HIV-1 infection;
At least 50 years of age;
Currently on a stable antiretroviral regimen (for ≥3 months preceding Screening) of either EVG/COBI/FTC/TAF (Genvoya) or EVG/COBI/FTC/TDF (Stribild);
HIV is currently suppressed, defined as:
Plasma HIV-1 RNA <50 c/mL for ≥3 months preceding Screening; AND
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:
Pregnant, breastfeeding, or planning to become pregnant during the study period;
Bilateral hip replacement;
Exceeds weight limit for DEXA equipment (i.e., weighs >350 lbs or >159 kg);
History or presence of allergy to the study treatment (Triumeq) or any of its components (to ABC, DTG, or 3TC);
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;
Positive for hepatitis B virus surface antigen (HBsAg) at Screening;
Ongoing malignancies (other than localized malignancies, such as cutaneous Kaposi's sarcoma, basal cell carcinoma, cervical intraepithelial neoplasia);
Significant suicidal risk in the investigator's opinion;
Metabolic disease;
Treatment with HIV immunotherapeutic vaccine within 90 days of Screening;
Radiation, cytotoxic chemotherapy, or any immunomodulator (that alters immune responses) within 28 days of Screening;
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;
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);
Became HIV-positive (i.e., had a detectable plasma HIV-1 viral load) while taking PrEP or PEP;
Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:
Historical genotype in the participant's medical record; OR
Genotype obtained by GenoSure Archive evaluation at Screening;
Any verified screening Grade 4 laboratory abnormality that in the investigator's opinion is clinically significant;
Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification;
Either of the following liver chemistry elevations:
Alanine amintotransferase (ALT) ≥5 x the upper limit of normal (ULN); OR
ALT ≥3 x ULN and bilirubin ≥1.5 x ULN (with >35% direct bilirubin);
Creatinine clearance (CrCl) of <50 mL/min (calculated by CockroftGault equation)
QT interval corrected for heart rate according to Bazett's formula (QTcB) ≥450 msec or QTcB ≥480 msec for participants with bundle branch block;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Mills, MD
Phone
310-550-2271
Email
tony.mills@millsclinicalresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Knight
Phone
310-550-2271
Email
ron.knight@millsclinicalresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony M Mills, MD
Organizational Affiliation
Mills Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mills Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Knight
Phone
310-550-2271
Email
ron.knight@millsclinicalresearch.com
First Name & Middle Initial & Last Name & Degree
Jake Collins
Phone
310-550-2271
Email
jake.collins@millsclinicalresearch.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC
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