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A Long-term Follow-up of the HIV-NAT Cohort

A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00411983
Enrollment
10000
Registered
2006-12-15
Start date
2002-11-01
Completion date
2030-12-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

chronic HIV infection, long term cohort of HIV infection

Brief summary

With HIV/AIDS increasingly considered a chronic disease, 24-, or 48-week data from antiretroviral studies are no longer sufficient. Only with long-term follow-up and outcome data will shed some much-needed light on the answers of questions that have stumped us for several years. Data from a large observational cohort of patients treated with combination antiretroviral therapy will provide further insights into the long-term safety and durability of various antiretroviral therapeutic approached, the efficacy of HIV viral load and CD4 cell counts as predictors of disease progression and mortality, and the importance of adherence.

Detailed description

Primary Objective: To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials. Secondary Objective: To Assess: 1. Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level 2. Incidence of lipodystrophy and other metabolic complications in three different groups of patients initially treated with NRTI-based regimens, NNRTI-based regimens, or PI-based regimens 3. Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir) 4. Resistance profiles in patients on different antiretroviral regimens 5. Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract 6. Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection 7. Immune recovery syndrome 8. Adherence to different antiretroviral regimens 9. Quality of life

Interventions

None listed

Sponsors

The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* HIV infected patients( children and adults) previously participated HIV-NAT studies * HIV infected patients( children and adults) currently participate in HIV-NAT trials * Able to provide written consent

Exclusion criteria

* Unable to provide written consent

Design outcomes

Primary

MeasureTime frameDescription
HIV infection30 yearsThis cohort will collect various information such as but not limited to: comorbidity, mortality, cardiovascular, neurological clinical data, treatment history, serious adverse events, PBMCs, clinical outcomes, virological outcomes, resistance, failure, aging, other opportunistic infections, etc

Countries

Thailand

Contacts

CONTACTAnchalee Avihingsanon, MD, PhD
anchalee.a@hivnat.org66 2 2557334-5
CONTACTStephen Kerr, PhD
s.kerr@unsw.edu.au66 2 2557334-5
PRINCIPAL_INVESTIGATORPraphan Phanuphak, MD, PhD

HIV-NAT, Thai Red Cross AIDS Research Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026