Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment

NCT02514707 | Unknown

• 1 other identifier: ST/0113/15
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS

Outcome Measures

Primary Outcomes (3)

• Characterize the clinical profile of patients (CD4 cell count, viral loads, WHO state, history of OIs, previous use of ART, level of anemia, and other medical conditions, drug mutations)

  A cross sectional analysis at study enrollment will be performed to characterize the clinical profile of patients after at least 9 years on ART including CD4 cell count, viral loads, WHO state, history of OIs, previous use of ART, level of anemia, and other medical conditions, drug mutations.

  Baseline

• Drug toxicity as any grade 3 & 4 DAD Scale

  To determine the incidence of side effects and drug toxicity, requirement for drug switches, development of opportunistic infections (OIs) (in particular tuberculosis), morbidity (particularly non HIV related morbidity such as cancer and cardiovascular diseases), medication adherence and loss to follow up; to determine the relationship between various clinical and demographic variables at initiation of treatment and cohort enrollment and subsequent outcome.

  Yearly for 10years

• Causes of mortality

  To investigate causes of mortality using a standardized collection tool for verbal autopsies

  Yearly for 10years

Secondary Outcomes (3)

• Composite measure of change in Sexual Behavior over time

  Yearly for 10years

• Variation of drug levels due to drug-drug interaction

  Yearly for 10years

• Cost Analysis

  Yearly for 10years

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 on ART for more than 9 years receiving care and treatment through the adult clinic at the Infectious Diseases Institute in Kampala, Uganda

You may qualify if:

• Age \>18 years
• Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• On the 10th consecutive year on ART (any combination including second line)

You may not qualify if:

• ART started before registration in the IDI clinic
• Subjects enrolled in an experimental clinical trial.

Sponsors & Collaborators

• Infectious Diseases Institute: lead

Study Sites (1)

Infectious Diseases Institute

Kampala, Kampala, 256, Uganda

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma (4 aliquots), serum (4 aliquots), packed cells pellets (5 aliquots) for each patient

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara Castelnuovo, MD, PhD

  Infectious Diseases Institute

  STUDY DIRECTOR

Central Study Contacts

Barbara Castelnuovo, MD, PhD

CONTACT

+256-312-307000; bcastelnuovo@idi.co.ug

Andrew D Kambugu, MMED

CONTACT

+256312307000; akambugu@idi.co.ug

Study Design

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

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 4, 2015
• Study Start: January 1, 2015
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: August 4, 2015

Record last verified: 2015-07

Locations

UG (1)