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HIV-1-infectionNCT04495348

Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance

An observational study of HIV-1-infection and Weight Gain, run by University of Colorado, Denver at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Weight gain following antiretroviral therapy (ART) initiation occurs with all modern regimens. Recent real-world reports suggest that integrase strand transfer inhibitor (INSTI)-based ART may be associated with excess weight gain compared to other regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1-infection, Weight Gain
What is being tested?
Doravirine
How many people
18 participants
Where
2 sitesUnited States
Study dates
22 Oct 2020to 5 Jun 2023
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with HIV who have experienced >10% weight gain on INSTI (bictegravir or dolutegravir-based therapy).

Who may be able to join

  • Adults age >=18 years
  • BMI of >=30.0 kg/m2
  • >=10% weight gain within the first 2 years of switching to INSTI-based ART (bictegravir or dolutegravir-based regimens only), with weight gain that has continued or worsened (not decreased).
  • At least one plasma HIV-1 RNA <50 copies/mL while on the current INSTI-based ART within 6 months of screening
  • Willing to switch to doravirine and pay any associated co-pays that may not be covered by insurance.
  • NRTI back-bone therapy with either TAF or TDF with 3TC or FTC and willing to continue these 2 agents

Who cannot join

  • Use of an INSTI other than bictegravir or dolutegravir within the 1 year prior to entry
  • Any plasma HIV-1 RNA >500 copies/mL within one year prior to entry
  • Pregnant, breast-feeding, or intention to become pregnant during the study period.
  • Participants using medications with a potential serious drug-drug interaction with doravirine that cannot be attenuated through dose change will also be excluded.
  • Any plans to change diet or exercise regimen significantly within the study period.
  • NOTE: Significantly refers to intent to join a weight-loss program such as Weight Watchers, start a specific diet (such as ketogenic or very low carbohydrate).
Show all 27Show fewer
  • Use of human growth hormone, tesamorelin, supra-physiologic testosterone to achieve therapeutic blood levels, or any use of other anabolic steroids within 3 months prior to study entry or plans to start these on study.
  • NOTE: Chronic, stable hormone replacement therapy ≥3 months prior to entry in men with diagnosed hypogonadism or transgender person on masculinizing hormonal therapy is permitted.
  • Use of estrogens or progesterones at supraphysiologic doses within 3 months prior to study entry.
  • NOTE: Stable doses used for contraception, post-menopausal hormone replacement or feminizing hormone therapy for transgender persons ≥3 months prior to entry is permitted.
  • Use of prednisone (or equivalent steroid) within the prior 3 months, unless stable dosing ≤ 10mg
  • Change or initiation of lipid- and/or glucose-lowering therapy in the 12 weeks prior to entry, or planned need for such therapy during the study period. Use of stable lipid- and/or glucose-lowering therapy during the study is allowed.
  • Current serious illness requiring systemic treatment and/or hospitalization until participant completes therapy or is clinically stable as determined by the site investigator.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Intent to use any medication likely to cause significant changes in weight during the study period.
  • NOTE: A list of medications in this category will be provided.
  • Prior bariatric surgery (e.g., lap band, gastric sleeve, or roux-en-y bypass surgery) or major gastric surgery or plans to undergo weight reduction surgery while on study.
  • Screening laboratory values as follows:
  • ANC < 500 cells/mm3 Hemoglobin < 9 gm/dL Cr Cl < 30 mL/min (estimated by CKD-Epi equation) Fasting blood sugar <200
  • Any chronic, end-stage organ disease that would impact metabolism, including end-stage liver or renal disease, cardiac cachexia, chronic obstructive pulmonary disease, or cancer
  • Any condition that the study investigator believes would make the candidate unsuitable for participation.
  • Severe claustrophobia that would limit ability of participant to remain in the whole room calorimeter
  • Known resistance to any component of the study drugs, including detection of any of the following resistance mutations on prior HIV genotype test (genotype testing not required if not available): Doravirine resistance: V106A, V106I, V106T, V106M, Y188C, Y188H, Y188L, G190E, P225H, F227C, F227L, F227R, M230L, L234I Resistance to NRTIs: K65R, K65E, K65N, T69S (insertion complex), K70E, L74V, Y115F, Q151M, M184I, M184V.
  • Active severe depression or anxiety, as evidenced by recent inpatient psychiatric admission (within the prior 6 months); PHQ-2 score of 6 (response of 'nearly every day' to 'do you have little interest or pleasure in doing things' or 'feeling down, depressed, or hopeless'; expressed suicidal ideations.
  • Under the care of a provider for disordered eating (bulimia, anorexia, or other).
  • Diabetes will be permitted if well-controlled with a Hb A1C of 7.5% of less in the prior 6 months and no use of insulin.
  • Routine physical activity meeting or exceeding 150 minutes/week of moderate or vigorous activity, for at least 3 months prior to the study

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • UTHealth

    Houston, Texas, 77030

Other trials in United States

About this study

Weight gain following antiretroviral therapy (ART) initiation occurs with all modern regimens. Recent real-world reports suggest that integrase strand transfer inhibitor (INSTI)-based ART may be associated with excess weight gain compared to other regimens. Weight gain appears to occur regardless of baseline weight, and is most pronounced among women and minorities, often those at highest risk of obesity-associated comorbidities. INSTI- and TAF-based regimens are now preferred regimens for most persons according to the Department of Health and Human Services ART-Treatment Guidelines. As a result, there is an urgent need to understand the underlying mechanisms for this weight gain.

This study aims to understand the changes in energy balance that occur with changes in ART. Participants with HIV who have experienced >10% weight gain on INSTI (bictegravir or dolutegravir-based therapy) will be switched to doravirine for 12 weeks, and then back to their prior INSTI regimen, allowing for assessment of changes in metabolic parameters with drug withdrawal and reintroduction (with no change to NRTI-backbone). Twenty-four hour energy balance will be measured on both regimens during a 24-hour stay using a whole room indirect calorimetry, with a standardized diet. Ultimately, the investigator's goal is to understand the mechanisms of weight gain so that future interventions can most effectively mitigate ART-associated weight changes.

Being tested
Doravirine
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoravirineDrug

    Participants will be switched to doravirine and then switched back to INSTI-based therapy to determine the impact on energy balance.

Study groups in NCT04495348
Study groupRoleWhat they receive
Open-label armParticipants are switched to doravirine and then switched back to INSTI-based therapy.
Receives: Drug: Doravirine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in energy balance

    Change in total energy expenditure (kcal/day)

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2020
  2. Study start22 Oct 2020
  3. Primary completion25 Jan 2023
  4. Study completion5 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04495348
Sponsor's protocol ID
19-2960
Status last verified
Jun 2023
First submitted
17 Jul 2020
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV-1-infection and Weight Gain, run by University of Colorado, Denver at 2 sites 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 27 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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in energy balance (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04495348.

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 22 Jun 2023; AzTrials last refreshed its copy on 3 Nov 2026.

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