HIV/AIDS Clinical Trial
— ART Long TermOfficial title:
Outcomes of HIV Infected Individuals After Ten Years on Antiretroviral Treatment
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age >18 years 2. 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. 3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. On the 10th consecutive year on ART (any combination including second line) Exclusion Criteria: 1. ART started before registration in the IDI clinic 2. Subjects enrolled in an experimental clinical trial. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Uganda | Infectious Diseases Institute | Kampala |
Lead Sponsor | Collaborator |
---|---|
Infectious Diseases Institute |
Uganda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Primary | Causes of mortality | To investigate causes of mortality using a standardized collection tool for verbal autopsies | Yearly for 10years | No |
Secondary | Composite measure of change in Sexual Behavior over time | To assess sexual behavior and sexual networks by routinely administered questionnaires through nurse counselors as well as to document over time the sero-status of the partners. | Yearly for 10years | No |
Secondary | Variation of drug levels due to drug-drug interaction | To investigate drug-drug interactions between antiretroviral drugs and concomitant medicines that are used by a sub-group of cohort subjects | Yearly for 10years | No |
Secondary | Cost Analysis | To investigate cost (cost analysis) of care of patients on long term ART and compare it with the cost of care of patients on short and middle (<10 years) ART. | Yearly for 10years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03413696 -
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
|
||
Completed |
NCT03215901 -
Life Plans Intervention Study
|
N/A | |
Completed |
NCT03289676 -
Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV
|
Phase 1 | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Active, not recruiting |
NCT04064567 -
Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK
|
N/A | |
Completed |
NCT04013295 -
Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya
|
N/A | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT03984136 -
HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM
|
N/A | |
Completed |
NCT02928900 -
Patient Actor Training to Improve HIV Services for Adolescents in Kenya
|
N/A | |
Recruiting |
NCT03268109 -
COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
|
||
Completed |
NCT02797262 -
Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System
|
N/A | |
Completed |
NCT02376582 -
Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS
|
Phase 1 | |
Completed |
NCT01957865 -
Real-Time Antiretroviral Therapy Adherence Intervention in Uganda
|
N/A | |
Terminated |
NCT01443923 -
Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV
|
Phase 4 | |
Completed |
NCT01616940 -
Minority AIDS Initiative Retention and Re-Engagement Project
|
N/A | |
Completed |
NCT01910714 -
Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth
|
N/A | |
Completed |
NCT01084421 -
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
|
N/A | |
Completed |
NCT01596322 -
International HIV Antiretroviral Adherence, Resistance and Survival
|
N/A | |
Completed |
NCT03643705 -
A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention
|
N/A | |
Completed |
NCT03923231 -
Pharmacokinetics of Atazanavir in Special Populations
|