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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The HIV Netherlands Australia Thailand Research Collaboration
Sponsor:
Information provided by (Responsible Party):
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00411983
First received: December 14, 2006
Last updated: August 26, 2014
Last verified: August 2014

December 14, 2006
August 26, 2014
November 2002
December 2020   (final data collection date for primary outcome measure)
HIV infection [ Time Frame: 30 years ] [ Designated as safety issue: No ]

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

Not Provided
Complete list of historical versions of study NCT00411983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

PBMC collection once a year

Non-Probability Sample

All HIV infected adult patients from HIV-NAT.

HIV Infections
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Thailand
 
NCT00411983
HIV-NAT 006
Yes
The HIV Netherlands Australia Thailand Research Collaboration
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
August 2014

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