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

Recruiting

• Conditions: HIV Infections

• Registration Number: NCT00411983
• Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

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

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2006-12-14
• Study First Submitted QC: 2006-12-14
• Study First Posted: 2006-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

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Exclusion Criteria

• Unable to provide written consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV infection	30 years	This 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

Trial Locations

Locations (1)

HIV-NAT, Thai Red Cross AIDS Research Center; 🇹🇭 Bangkok, Thailand