Effects of ART Simplification on Inflammatory Markers in CoRis (AIR)

NCT03501719 | Completed FDA Drug

• 1 other identifier: 133-17
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of the number of drugs included in antiretroviral therapy (ART) regimens of inflammatory markers remains undefined. We will evaluated in participants in the Spanish AIDS Research Network, whether triple ART, dual ART or monotherapy affect differentially the dynamics of inflammatory markers.

Conditions

HIV

Keywords

HIV; inflammation; antiretroviral therapy; cohort studies; mortality; non-AIDS events

Outcome Measures

Primary Outcomes (1)

• Inflammation

  Plasma IL-6 levels in plasma

  From baseline through study completion, an average of 3 years

Secondary Outcomes (11)

• Immune activation

  From baseline through study completion, an average of 3 years

• Coagulation

  From baseline through study completion, an average of 3 years

• Gut epithelial integrity

  From baseline through study completion, an average of 3 years

• Monocyte activation/bacterial translocation

  From baseline through study completion, an average of 3 years

• Immunological variables

  From baseline through study completion, an average of 3 years

Study Arms (3)

Triple ART

Patients who remain in triple ART during the follow-up.

Drug: Number of drugs in the ART regimen

Dual ART

Patients switched to dual ART during the follow-up.

Drug: Number of drugs in the ART regimen

Monotherapy

Patients switched to monotherapy during the follow-up.

Drug: Number of drugs in the ART regimen

Interventions

Number of drugs in the ART regimen DRUG

Triple therapy vs. dual therapy vs. monotherapy

Dual ART; Monotherapy; Triple ART

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected patients

You may qualify if:

• Subjects initiating ART in CoRIS from 2004 with triple therapy.
• HIV RNA suppression achieved in the first 48 weeks of ART.

You may not qualify if:

• ART initiation with regimens with less than three drugs
• Virologic failure in the first 48 weeks of ART
• AIDS conditions or serious non-AIDS events in the first 48 weeks of ART.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples stored at the biobank of the Spanish AIDS Research Network.

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 18, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

ES (1)