Could an HIV belly-fat drug also sharpen memory?
NCT ID NCT02572323
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether tesamorelin, a drug already approved for belly fat in HIV, could improve memory and thinking in 73 older HIV patients with mild cognitive problems. Participants also used a text-messaging app to stay motivated. The trial measured changes in brain performance and a related blood marker over 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tesamorelin (Egrifta), an injectable drug approved for abdominal fat in HIV
- What this could lead to
- If it works, this could point toward a treatment for memory and thinking problems in people living with HIV.
- What could go wrong
- This is a small, early Phase 2 trial with only 73 participants. The results may not be strong enough to confirm benefit, and tesamorelin is not yet proven for cognition.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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73 people
The number who actually took part.
- Started
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Feb 2017
- Finished
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Oct 2023
- Lead sponsor
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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
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40 years and older
- Sex
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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: * HIV-1 infection documented by any FDA licensed clinical test including HIV enzyme/antigen test or chemiluminescence immunoassay (E/CIA) or plasma HIV-1 RNA viral load. * Antiretroviral therapy: Patient currently receiving a combination antiretroviral therapy (cART) regimen ≥12 weeks with no interruptions longer than 7 days and HIV \<500 copies/ml during that time. * Men or women 40 years of age and older * Abdominal minimal waist circumference ≥ 95cm for men and ≥94cm for women or minimal waist to hip ratio of ≥ 0.88 for women (each based on an average of three separate measurements) * Screening neuropsychological Global Deficit Score of ≥ 0.35 * The following laboratory values obtained within 90 days prior to entry by any CLIA certified laboratory. * Absolute neutrophil count (ANC) ≥750/mm3 * Hemoglobin ≥8.0 g/dL * Platelet count ≥50,000/mm3 * HgbA1C ≤8.0% * Calculated creatinine clearance of ≥20 mL/min as estimated by the Cockroft-Gault formula * Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT) \<5 X upper limit of normal (ULN) and alkaline phosphatase \<3 X upper limit of normal (ULN) without evidence of active liver disease other than non-alcoholic fatty liver disease (NAFLD) or hepatitis C requiring treatment. * Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is acceptable). * For females of reproductive potential, negative serum or urine pregnancy test within 30 days prior to entry by any test performed by a CLIA certified laboratory or is using a point of care (POC)/ CLIA-waived test. * Contraception requirements: For females of reproductive potential, she or male partner is willing to use a contraceptive during sexual intercourse. * Ability and willingness of participant or legal guardian/representative to provide informed consent Exclusion Criteria: * Clinical contraindications * History of neurocognitive confounding conditions that explain current impairment including but not limited to stroke, head injury, psychotic disorder, active substance use disorder by DSM, or opportunistic CNS infection * Hepatitis C virus infection defined as HCV antibody positive requiring treatment and plans for treatment during study therapy * Active or relapsing autoimmune disorder that may require immunotherapy during this treatment trial * Active malignancy other than basal or squamous skin cancer. * Breastfeeding or pregnancy * Excluded medications used within the last 90 days: active or planned use of rhGH, anabolic steroids (other than replacement doses of testosterone), anti-TNFa therapy or other biologic (tocilizumab, Xelijanz, etc.) * Anticipated need to start new daily anti-inflammatory therapy such as NSAIDs (excluding aspirin for vascular prophylaxis), systemic corticosteroids, or anti-malarials, or plan to discontinue regular dosing with these drugs during study treatment. * Known allergy/sensitivity or any hypersensitivity to tesamorelin * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to entry * Use of tesamorelin in the last 6 months
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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
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HIV Neurobehavioral Research Program (HNRP)
San Diego, California, 92103, United States
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Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033, United States
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PalmTree
Palm Springs, California, 92262, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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