Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00411983
Recruitment Status : Recruiting
First Posted : December 15, 2006
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
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.

Condition or disease
HIV Infections

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10000 participants
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
Actual Study Start Date : November 2002
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. HIV infection [ Time Frame: 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

Biospecimen Retention:   Samples With DNA
PBMC collection once a year

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All HIV infected adult patients from HIV-NAT.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00411983

Layout table for location contacts
Contact: Anchalee Avihingsanon, MD, PhD 66 2 2557334-5 ext 107
Contact: Stephen Kerr, PhD 66 2 2557334-5 ext 138

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Praphan Phanuphak, MD, PhD HIV-NAT, Thai Red Cross AIDS Research Center

Additional Information:
Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The HIV Netherlands Australia Thailand Research Collaboration Identifier: NCT00411983     History of Changes
Other Study ID Numbers: HIV-NAT 006
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
Layout table for MeSH terms
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