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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by The HIV Netherlands Australia Thailand Research Collaboration.
Recruitment status was  Recruiting
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
First received: December 14, 2006
Last updated: February 3, 2011
Last verified: February 2011

December 14, 2006
February 3, 2011
November 2002
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Complete list of historical versions of study NCT00411983 on ClinicalTrials.gov Archive Site
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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

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.

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
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA

PBMC collection once a year

Non-Probability Sample

All HIV infected adult patients from HIV-NAT.

HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2012
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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
18 Years and older
Contact: Anchalee Avihingsanon, MD 66 2 2557334-5 ext 107 anchalee.a@hivnat.org
Contact: Stephen Kerr, PhD 66 2 2557334-5 ext 138 s.kerr@unsw.edu.au
Prof. Praphan Phanuphak, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Not Provided
Principal Investigator: Praphan Phanuphak, MD, PhD HIV-NAT, Thai Red Cross AIDS Research Center
The HIV Netherlands Australia Thailand Research Collaboration
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP