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HIV drug switch may boost heart health and trim body fat

NCT ID NCT05289986

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether switching from a standard HIV drug combination to a different one (Delstrigo) could improve cholesterol, body fat, and blood sugar in people with HIV. The study planned to enroll 60 adults whose HIV was already well-controlled. Participants were randomly assigned to switch medications right away or after 24 weeks. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

19 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * HIV-1 infected, 18 years or older * On stable \& suppressive triple cART containing ABA/3TC or TAF/FTC plus dolutegravir or bictegravir for at least 6 months * No evidence of resistance to TDF, 3TC, or DOR * No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators * Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol: * Implant * Depot injection * Intra-uterine device or system * Oral hormonal contraception A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. * Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the subject's entry into the study) Exclusion Criteria: * History of virological failure on an NNRTI in absence of a post-failure genotypic resistance test proving absence of resistance to DOR * Concomitant medication contra-indicated with TDF, FTC or DOR * Haemoglobin \<9 g/dL * Platelets \<80,000/mm3 * Creatinine clearance \<50 mL/min * AST or ALT ≥5N * Acute Hepatitis A infection. * Concomitant DAA for anti-HCV therapy * Known acute or chronic viral hepatitis B or C. o Individuals with positive anti-HCV results, but with HCV RNA not detected may be included on the trial. * Pregnant or breastfeeding women, or individuals actively trying to conceive * History of osteoporosis or bone fractures/loss * Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations * Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, London, SW10 9NH, United Kingdom

  • Mortimer Market Centres

    London, London, WC1E6JB, United Kingdom

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