Fasting Mimicking Diet in people living with the human immunodeficiency virus

Phase 1

Conditions: Patients with HIV infection under effective antiretroviral therapy
B20-B24
Human immunodeficiency virus [HIV] disease

Registration Number: DRKS00033785

Lead Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn vertreten durch die Medizinische Fakultät der Universität Bonn vertreten durch den Dekan der Medizinischen Fakultät

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 45

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 < 1.5 mg/dl or calculated creatinine clearance =50
mL/min
- Uric acid < 6 mg/dl
- Fasting glucose > 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

- 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 <50%)
- Impaired liver function (total bilirubin > 2 mg/dl or AST/ALT 2-fold

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunological effects of FMD

Secondary Outcome Measures

Name	Time	Method
- Safety of the FMD<br>- Feasibility of the FMD<br>- Metabolic effects <br>- Changes in the intestinal microbiome<br>- Influence on body weight<br>- Influence on blood count, liver values, retention parameters