Clinical trial NCT03542786: Clinical Trial to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic
Official title: Clinical Trial, Randomized and Controlled With Placebo to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic, Only or in Conjunction of a Pre-biotical, in Adults Infected by Hiv-1 With a cd4 Record Less Than 500 Cells / mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Premature Aging
Keywords: HIV-1
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
Collaborators: name: Germans Trias i Pujol Hospital
First posted: 2018-05-31
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 patients will be included in this trial. Patients will be randomized 2: 2: 1 to one of the following 3 branches according to the use of integrase inhibitors (INI), protease inhibitors (PI) or non-nucleoside analogue reverse transcriptase inhibitors ( ITINAN) and according to the CD4 count nadir is greater or less or equal to 200 cells / mm3: Branch A: add probiotic i3.1 to the antiretroviral therapy Branch B: add probiotic i3.1 and ProSeed prebiotic to the antiretroviral therapy Branch C: add placebo to ART The treatment periods will be of 6 months and follow-up will be carried out at month, at 3 months and at 6 after the start of the study treatment, and a last visit will be made at 3 months after discontinuing it (wash-out period).
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).

Detailed description: It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years old.
* Documented HIV-1 infection.
* Be in treatment with these antiretrovirals (INI, IP, ITINAN) during 12 months.
* HIV-1 Viral titer \<50 copies/mL during 6 months.
* CD4\> 500 cells/mm3.

Exclusion Criteria:

* Treatment with antibiotics.
* Severe diseases actives.
* Defining diseases of AIDS in the previous year.
* Gut surgery except appendectomy or cholecystectomy.
* Pregnancy.
* Any diet deviation (vegans).
* Other probiotic treatment.

Primary outcomes:
measure: The appearance of adverse effects.
timeFrame: Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).
Secondary outcomes:
measure: Gut microbiota diversity and metabolomic profile
timeFrame: A measure will be made in V1, V2, V3 and V4 (1 month, 3 months, 6 months and 9 months after the treatment beginning, respectively).
measure: Translocational bacterial markers & Systemic inflammation markers
timeFrame: A measure will be made in V1 and V2 (1 month and 3 months after the treatment beginning, respectively).
measure: Cluster of Differentation 4 (CD4) count
timeFrame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
measure: CD4/CD8 ratio
timeFrame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
measure: Satisfaction with the product
timeFrame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
measure: Questionaire to evaluate the life quality
timeFrame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
measure: Questionaires to evaluate the anxiety and depression
timeFrame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
Study officials:
affiliation: AB-Biotics
name: Ariana Salavert, PhD
role: STUDY_DIRECTOR
References: