Efficacy and Safety of Low-Dose Colchicine on Surrogate Markers of Cardiovascular Events in People Living With HIV Receiving Antiretroviral Therapy

NCT05168137 | Unknown Phase 4 DMC

• 1 other identifier: MURA2020/762
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In a double-blind, randomized controlled trial, we assigned PLWH receiving ART without a history of cardiovascular events to received colchicine 0.6 mg once daily or placebo. The primary endpoint was the mean difference of hs-CRP, IL-6, and IL-1 Ra levels at three and six months. The secondary endpoint was to access safety outcomes.

Conditions

HIV Infections; Inflammatory Markers; Colchicine Adverse Reaction

Keywords

colchicine; HIV; PLWH; hs-CRP; IL-6; IL-1 Ra; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Decline of hs-CRP

  Decline of hs-CRP comparing to the baseline

  6 months

Secondary Outcomes (1)

• Decline of IL-6

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

prescribed placebo of colchicine

Drug: Placebo

Colchicine

ACTIVE COMPARATOR

Prescribed colchicine 0.6 mg PO daily

Drug: Low-dose colchicine

Interventions

Low-dose colchicine DRUG

prescribed colchicine 0.6 mg/day

Colchicine

Placebo DRUG

Placebo of colchicine

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PLHIV receiving ART (TDF/FTC/EFV, TDF/FTC+RPV, TDF+3TC+RPV, TDF/3TC/DTG, or ABC/3TC/EFV) for more than 6 months
• hs-CRP \>=2 mg/mL
• Agree to participate the study

You may not qualify if:

• Those who has contraindication for colchicine
• Those who had history of allergy to colchicine
• Those who was diagnosed with myocardial infarction or ischemic stroke
• Those who was diagnosed with cirrhosis child B or C
• Those who had eGFR \<30 ml/min/1.73 m2)
• Those who had HIV viral load more than 40 copies/mL in 6 months before entering the study
• Those who has CD4 less than 300 cells/mm3
• Deny to participate the study

Sponsors & Collaborators

• Mahidol University: lead
• Thai AIDs society: collaborator

Study Sites (1)

Angsana Phuphuakrat

Ratchathewi, ฺBangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized, double blind, controlled study

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 23, 2021
• Study Start: February 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

TH (1)