Patients with HIV infection under effective antiretroviral therapy B20-B24
Conditions
Interventions
Group 1: HIV(+) patients on effective therapy undergoing multiple cycles of a fasting mimicking diet (FMD) (study group)
Group 2: HIV(+) patients under effective therapy who eat a regular diet (contro
Sponsors
Rheinische Friedrich-Wilhelms-Universität Bonn vertreten durch die Medizinische Fakultät der Universität Bonn vertreten durch den Dekan der Medizinischen Fakultät
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - HIV infection under therapy - Ability to swallow plant foods - Body mass index (BMI) = 20 kg/m2 - Haemoglobin > 9 g/dl - Normal white blood cell count - Creatinine 65 mg/dl - Total bilirubin < 2 mg/dl or < ULN - Written informed consent - Willingness and ability to perform blood, stool and urine analyses - Ability to remain in daily contact (by phone or email) with study personnel to provide key clinical information, including daily body weight, blood pressure, health status and adverse events on each of the five days of the diet
Exclusion criteria
Exclusion criteria: - Unintentional weight loss = 5% in the last 3-6 months - Known HCV and/or HBV co-infection - Existing or planned pregnancy (positive pregnancy test in women, e.g. ß-HCG test in urine/serum) or breastfeeding - Diagnosis of type I or type II diabetes mellitus requiring medical treatment - Fasting glucose > 200 mg/dl - Impaired renal function (creatinine > 1.5mg/dl; GFR 2 mg/dl or AST/ALT 2-fold ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological effects of FMD | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety of the FMD - Feasibility of the FMD - Metabolic effects - Changes in the intestinal microbiome - Influence on body weight - Influence on blood count, liver values, retention parameters | — |
Countries
Germany
Contacts
Public ContactJacob Nattermann
Medizinische Klinik und Poliklinik I, Universitätsklinikum Bonn
Outcome results
None listed