Infection, Human Immunodeficiency VirusSTRUCTRNCT03275701
Evaluating BMD in Participants ≥50 Years Old Switching From EVG/COBI/FTC/TAF or EVG/COBI/FTC/TDF to ABC/DTG/3TC
A study testing Triumeq in people with Infection, Human Immunodeficiency Virus, run by Mills Clinical Research at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- Triumeq
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Mills Clinical Research
Los Angeles, California, 90069
Ron Knight, 310-550-2271, ron.knight@millsclinicalresearch.com
Jake Collins, 310-550-2271, jake.collins@millsclinicalresearch.com
About this study
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)
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)
Read the 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
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- Triumeq
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriumeqDrug
Open Label, Switch to Triumeq (ABC/DTG/3TC)
| Study group | Role | What they receive |
|---|---|---|
| Triumeq | Other | Single Arm, Open Label Receives: Drug: Triumeq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA)
Measured: 48 Weeks
Percent change from Baseline at Week 48 in lumbar spine BMD (measured by DEXA)
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study startJul 2016
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mills Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Responsible party
- Principal investigator, Anthony Mills MD, Mills Clinical Research
- Investigators
- Anthony M Mills, MD, Principal investigator, Mills Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275701
- Sponsor's protocol ID
- 205773
- Acronym
- STRUCTR
- Status last verified
- Sep 2017
- First submitted
- 22 Jul 2016
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03275701
- Acronym / sponsor ID
- STRUCTR / 205773
- Conditions
- Infection, Human Immunodeficiency Virus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mills Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- ViiV Healthcare
- Study start
- Jul 2016
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triumeq | Other | Drug: TriumeqSingle Arm, Open Label |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriumeqOpen Label, Switch to Triumeq (ABC/DTG/3TC) | Drug | Triumeq |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony M Mills, MD principal investigator
Mills Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triumeq in people with Infection, Human Immunodeficiency Virus, run by Mills Clinical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Mills, MD (310-550-2271, tony.mills@millsclinicalresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from Baseline at Week 48 in total hip BMD (measured by DEXA) (time frame: 48 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.