Facial Lipoatrophy Trial: Immediate Versus Deferred Injections of Poly-L-Lactic Acid for HIV Facial...
HIV-Associated LipodystrophyHIV InfectionsThis is a multi-centre, open-label, 96 week study to evaluate the safety, tolerability and extent and duration of improvement in HIV-1 infected subjects with antiretroviral induced facial lipoatrophy, randomised in a 1:1 ratio to receive immediate or deferred deep subcutaneous injections of poly-L-lactic acid (PLA). Subjects will receive 4 treatments of PLA approximately every 2nd week, either at trial entry or following a delay period of 24 weeks.
Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
LipodystrophyThe octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled...
HIV-Associated Lipodystrophy SyndromeHIV InfectionsThe aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.
Effects of IGF-I in HIV Metabolic Disease
HIV LipodystrophyThis study examines the effects of recombinant insulin like growth factor - I on body composition, glucose homeostasis, and lipids, in adults with HIV infection and signs of metabolic disease.
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial...
Familial Partial LipodystrophyThe purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 52 weeks in a randomized treatment (RT) period in participants with familial partial lipodystrophy (FPL). Following the randomized treatment period, participants who did not enter the open-label extension (OLE) period went straight to the 13-week post-treatment (PT) follow-up period and participants who were entered in the OLE period continued to receive volanesorsen for another 52 weeks (Weeks 53 to 104). Following the Week 104 visit of the OLE period, participants had an option of continued dosing for up to an additional 52 weeks (Week 105 to 156). Participants who did not enter the OLE period went straight to a 13-week post-treatment follow-up period. Following the Week 104 OLE period, participants were entered a 13-week post-treatment follow-up period, if they did not choose the option for continued dosing.
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
HIV InfectionsHIV-Associated Lipodystrophy SyndromeThe aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).
The PREFORM Study: Rotational Fractional Resection for Submental Contouring
Skin LaxityLipodystrophyThis study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. Rotational fractional resection is used to remove loose skin and fat.
Metabolic Abnormalities in HIV-infected Persons
LipodystrophyHIV InfectionThe purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.
Effects of Growth Hormone Releasing Hormone in HIV
HIVHIV LipodystrophyHIV-infection and its treatment are often associated with an increase in belly fat, as well as abnormal cholesterol and problems metabolizing sugar. People with HIV infection and increased belly fat often have decreased growth hormone (GH) levels. Low GH levels may contribute independently to increased belly fat and to increased cardiovascular risk through effects on sugar metabolism, inflammation, and other mechanisms. Tesamorelin, a growth hormone releasing hormone (GHRH) analogue, has been shown to to reduce belly fat in patients with HIV-associated abdominal fat accumulation. However, the effects of tesamorelin on fat accumulation in the liver and muscle, sugar metabolism, and cardiovascular health are not yet known. The current study is designed to determine the effects of tesamorelin treatment on fat accumulation in the muscle and liver, insulin sensitivity and sugar metabolism, and markers of cardiovascular health including blood vessel thickness (carotid intima media thickness [cIMT]) and markers of inflammation in the body. The investigators hypothesize that tesamorelin will decrease fat accumulation in the liver and muscle and will decrease markers of inflammation, with either neutral or beneficial effects on glucose metabolism.
Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With...
HIV-Associated Lipodystrophy SyndromeAim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons. Design: Pilot, prospective, open, randomized, controlled 3-year study. Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4 cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3. Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200 copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.