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

NCT03275701 | Unknown

• 1 other identifier: 205773
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  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

Study Arms (1)

Triumeq

OTHER

Single Arm, Open Label

Drug: Triumeq

Interventions

Triumeq DRUG

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

Triumeq

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Mills Clinical Research: lead
• ViiV Healthcare: collaborator

Study Sites (1)

Mills Clinical Research

Los Angeles, California, 90069, United States

RECRUITING

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

abacavir, dolutegravir, and lamivudine drug combination

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony M Mills, MD

  Mills Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Mills, MD

CONTACT

310-550-2271; tony.mills@millsclinicalresearch.com

Ron Knight

CONTACT

310-550-2271; ron.knight@millsclinicalresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Director

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: September 7, 2017
• Study Start: July 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)