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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2030
  • participants needed
    10000
  • sponsor
    The HIV Netherlands Australia Thailand Research Collaboration
Updated on 25 January 2021
antiretroviral
antiretroviral agents
antiretroviral therapy
hiv viral load
AIDS
HIV Vaccine

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.

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

Details
Condition HIV infection, Immunodeficiency, Primary Immunodeficiency Disorders, HIV Infections, human immunodeficiency virus, hiv disease
Clinical Study IdentifierNCT00411983
SponsorThe HIV Netherlands Australia Thailand Research Collaboration
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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