An interventional study of Triumeq in Infection, Human Immunodeficiency Virus, sponsored by Mills Clinical Research. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Mills Clinical Research · Not applicable, Interventional, and Treatment
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)
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
HIV is currently suppressed, defined as:
Exclusion Criteria:
Documented resistance to any component of the study treatment (ABC, DTG, or 3TC) as indicated by either:
Either of the following liver chemistry elevations:
Single Arm, Open Label
Drug: Triumeq
Open Label, Switch to Triumeq (ABC/DTG/3TC)
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
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
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
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
Plan to share: Yes
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Acquired Immunodeficiency Syndrome→