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Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment

NCT02514707 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2015-08-04

No results posted yet for this study

Summary

Study Title: Outcomes of HIV infected individuals after ten years on antiretroviral treatment Short Title/Study ID: ALT cohort Protocol Version and Date: Version 1.0 June 2013 Clinical Phase: NA Methodology: Prospective observational study Study Duration: 01 January 2014- 30th June 2025 Study Centre(s): Single centre (Infectious Diseases Institute, Kampala, Uganda) Number of Subjects: Enrollment of 1,000 study participants. All patients discharged from the IDI Research cohort (10 years of follow up on ART) will be offered to participate in the study. Additional patients with similar characteristics will be enrolled from he clinic Diagnosis and Main Inclusion Criteria: HIV patients above 18 years and in their 10th year of ART Main Exclusion Criteria: ART started outside IDI Study Product, Dose, Route, Regimen: ART will be provided according to standard of care at IDI and according to the WHO and Ugandan guidelines Duration of follow up: 10 years Reference therapy, Dose, Route, Regimen: Not applicable Recruitment Schedule: 1 January 2014- 30 June 2015 Statistical Methodology: Time to event analysis (end of treatment, failure, death, switch, occurrence of drug toxicities) including Kaplan-Meier curves and Cox regression will be performed. Endpoints will be correlated with characteristics at ART start and at study enrollment. Possible confounding variables, if available, will be considered.

GCP Statement: This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, and ICH-GCP as well as all national legal and regulatory requirements.

Conditions

Sponsors & Collaborators

  • Infectious Diseases Institute

    lead OTHER

Principal Investigators

  • Barbara Castelnuovo, MD, PhD · Infectious Diseases Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02514707 on ClinicalTrials.gov