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
  Purpose

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.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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



Biospecimen Retention:   Samples With DNA

PBMC collection once a year


Estimated Enrollment: 2000
Study Start Date: November 2002
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All HIV infected adult patients from HIV-NAT.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411983

Contacts
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

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Center Recruiting
Bangkok, Thailand, 10330
Principal Investigator: Praphan Phanuphak, MD, PhD         
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Investigators
Principal Investigator: Praphan Phanuphak, MD, PhD HIV-NAT, Thai Red Cross AIDS Research Center
  More Information

Additional Information:
Publications:

Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier: NCT00411983     History of Changes
Other Study ID Numbers: HIV-NAT 006
Study First Received: December 14, 2006
Last Updated: August 26, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
chronic HIV infection
long term cohort of HIV infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on October 01, 2014