Last reviewed · How we verify
NCT04165200
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
NA trial testing Blood and feces samples in HIV Infections in 22 participants. Completed in 20 January 2020.
10 June 2019
Quick facts
| Lead sponsor | Hospital Universitario Dr. Jose E. Gonzalez |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 6 September 2018 |
| Primary completion | 10 June 2019 |
| Estimated completion | 20 January 2020 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Blood and feces samples
Conditions studied
- HIV Infections — all drugs for HIV Infections →
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Who can join
18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients eligible for the study will be selected on Fridays during the HIV consultation at the Infectious Diseases Department. Patients that meet the inclusion and exclusion criteria, will be randomized and assigned in two groups 1:1. A group will start intervention with FMT (fecal matter transplant) through frozen capsules and after seven days, antiretroviral therapy (ART) will be started. Patients in the other group will be given placebo capsules and after seven days ART will be started. The frozen capsules of FMT will be ingested orally with a frequency of 15 capsules every 12 hours for 4 doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Subsequently, blood samples will be taken to monitor the immune status with CD4 T lymphocytes and HIV viral load during week 0, 4, 8, 12 and 24 after ART start. Throughout the study period, subjects can carry out a free diet, moderate alcohol intake, perform their daily activities and abstain from any of the elimination criteria. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treating From the Inside Out: Relevance of Fecal Microbiota Transplantation to Counteract Gut Damage in GVHD and HIV Infection.
Ouyang J, Isnard S, Lin J, Fombuena B, et al · · 2020 · cited 20× · PMID 32850913 · DOI 10.3389/fmed.2020.00421 -
Lights and Shadows of Microbiota Modulation and Cardiovascular Risk in HIV Patients.
Villoslada-Blanco P, Pérez-Matute P, Oteo JA. · · 2021 · cited 4× · PMID 34202210 · DOI 10.3390/ijerph18136837
Verify or expand the search:
- PubMed search for NCT04165200
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for HIV Infections
Currently open trials in the same condition.
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
- NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
- NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
- NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting
Other Hospital Universitario Dr. Jose E. Gonzalez trials
Trials by the same sponsor.
- NCT07401992 — Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis · Phase 4 · recruiting
- NCT06758375 — Low Dose Teclistamab in Newly Diagnosed Multiple Myeloma Patients · Phase 2 · recruiting
- NCT06904599 — Efficacy of Human Chorionic Gonadotropin in Acute GVHD Treatment · Phase 2 · recruiting
- NCT07039877 — Efficacy of Low-dose Venetoclax With Itraconazole + TACL for R/R ALL Patients · Phase 2 · recruiting
- NCT06209190 — Safety and Feasibility of TMLI as Conditioning Regimen in Allogeneic Hematopoietic Stem-cell Transplantation · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04165200 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario Dr. Jose E. Gonzalez
- Last refreshed: 28 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04165200.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing