A Prospective Cohort for ex Vivo Cure Studies With Chronic HIV Infected Patients in the Netherlands

NCT04888754 | Active Not Recruiting

• 1 other identifier: NL72765.078.20
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective non-interventional cohort study at Erasmus MC of adult chronic HIV infected patients of ≥18 years of age who initiate antiretroviral therapy in routine care.

Conditions

HIV Infections; HIV-1-infection; HIV-2 Infection

Keywords

HIV; HIV cure; HIV reservoir

Outcome Measures

Primary Outcomes (2)

• To develop a prospective cohort in the Netherlands of chronic HIV infected patients within-depth reservoir characterization for future cure interventions.

  The HIV latent reservoir will be characterised in chronic HIV patients using novel techniques like FISH-flow

  5-10 years

• To study the evolution of the HIV reservoir and immune host responses over time during antiretroviral therapy.

  The HIV reservoir will be characterised over time to study the dynamics of the reservoir

  5-10 years

Secondary Outcomes (3)

• To explore established and putative new interventions aimed at curing HIV.

  5-10 years

• To explore differences in reservoir size, activity and host responses, and their relation with clinical characteristics, between patients with different dominant HIV subtypes and sexes.

  5-10 years

• To compare and validate new reservoir assays with current established assays.

  5-10 years

Eligibility Criteria

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

Study Population

Patients are 18 years or older with a confirmed HIV infection without prior exposure to cART (treatment naïve). Prior use of pre-exposure prophylaxis is allowed.

You may qualify if:

• Age \>18 years.
• Confirmed HIV-1 or HIV-2 infection
• Judged willing to initiate and adhere to cART by the HIV physician.

You may not qualify if:

• Inability to place venous catheters to draw blood.
• Major comorbidities:
• Severe symptomatic anemia or recent symptomatic cardiovascular event (un-stable angina pectoris, decompensated heart failure, myocardial infarction).
• The inability to participate due to any other relevant social, environmental,psychological, factors or according to the HIV treating physician's judgement.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and leucapheresis

MeSH Terms

Conditions

HIV Infections

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

Study Officials

• Casper Rokx, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

• Tokameh Mahmoudi, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 17, 2021
• Study Start: May 26, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2034
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

NL (1)