HIV pill combo fails to slim belly fat in early trial
NCT ID NCT01420523
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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Apr 2013
- Lead sponsor
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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
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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 Hide 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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Other studies related to the condition(s) this trial covers.
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