Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients. (NCT02258685) | Clinical Trial Compass
CompletedNot Applicable
Factors Mediating Gut Microbiota Dysbiosis and Metabolic Disease in HIV Patients.
United States93 participantsStarted 2014-11
Plain-language summary
This study plans to learn more about immune responses in intestinal (gut) tissue in people with human immunodeficiency virus (HIV) infection. This study will determine whether change in the composition of gut bacteria in HIV infected individuals is related to a high prevalence of chronic gut inflammation and metabolic disease. The investigators will also investigate immune-modulatory properties of specific bacteria that correlate with disease both by characterizing which functional genes are selected for in their genomes and by stimulating immune cells isolated from blood and gut tissue with bacterial isolates. This work will establish whether gain/loss of bacterial drivers/suppressors of information in the gut contributes to metabolic disease in HIV-infected individuals.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women; 18 years to 65 years (All Cohorts)
* Subjects with chronic HIV-1 Infection defined as a positive ELISA confirmed by a positive Western Blot or plasma HIV-1 RNA level \>1,000 copies/mL at any time in the past. (Cohorts A1, A2 \& A3)
* HIV-1 seronegative (Cohort A4)
* Either with or without lipodystrophy (to be assessed at Visit 1)
* Body mass index (BMI) between 21-29 mg/kg2 and weight stable for at least 3 months (All Cohorts)
* Antiretroviral therapy (ART) naïve (Cohort A3): \<10 days of ART treatment at any time prior to Visit 1 or previously on ART but off treatment for the previous 6 months prior to Visit 1
* Long-term ART (Cohort A1 \& A2): Must be on same antiretroviral treatment and have a plasma HIV-1 RNA \<25 copies/mL for 3-6 months prior to Visit 1.Liver function tests not greater than 2x normal, normal kidney and thyroid function. Fasting glucose must be \<110 mg/dl
* Liver function tests not greater than 2x normal, normal kidney and thyroid function. Fasting glucose must be \<110 mg/dl
* ART-treated individuals whose microbiota resembles those with untreated HIV infection and ART-treated individuals whose microbiota resembles the HIV-negative control cohort (equal numbers with and without lipodystrophy).(Cohort B; a subset of Cohort A)
Exclusion Criteria:
* Gastrointestinal disease such as inflammatory bowel disease, Clostridium difficile colitis or celiac sprue.
* history of bowel resection, bleeding disorder, history of h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the gut microbiota composition using 16S ribosomal RNA (rRNA) sequencing of fecal samples
Timeframe: 2 months
2
Determine of gut microbiota composition using rectosigmoid biopsy tissue