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HIV pill combo fails to slim belly fat in early trial

NCT ID NCT01420523

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether switching to a two-drug HIV treatment (raltegravir plus maraviroc) could reduce belly fat (lipohypertrophy) in people whose HIV was already well-controlled. It included 48 adults on stable HIV therapy for at least 5 years. The study was stopped 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

48 people

The number who actually took part.

Start date

Dec 2011

Finished

Apr 2013

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Patients infected with HIV-1 type B or CRF02. * ≥ 18 years old * Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months. * Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and \< 50 copies/mL for at least 12 months. * Patients with an R5\* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3 * Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump). * Patients who have never been treated with raltegravir. * Patients who have never been treated with maraviroc. * Efficient contraception for women * Free and informed written consent, signed by the patient and the investigator. * Patients with health insurance. \* To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno\[coreceptor\] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%. Exclusion Criteria: * X4, X4/5 or undetermined tropism of the HIV virus. * HIV-2 or coinfection HIV-1/HIV-2. * Chronic viral hepatitis B. * Chronic viral hepatitis C requiring specific treatment over the first 24 weeks. * Treatment with growth hormones. * Hypolipemic or diabetes treatment, begun within the last 3 months. * Pregnant or breastfeeding women. * Haemoglobin \< 7g/dl, neutrophils \< 500/mm3, platelets \< 50 000/mm3, creatinine clearance \< 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N). * Antiretroviral treatment associated to enzymatic inducer. * Chronic alcohol consumption. * Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship. * Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.

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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

  • Hôpital Pitié Salpétrière

    Paris, 75013, France

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