A Long-term Follow-up of the HIV-NAT Cohort
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ClinicalTrials.gov Identifier: NCT00411983 |
Recruitment Status
:
Recruiting
First Posted
: December 15, 2006
Last Update Posted
: February 24, 2017
|
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Condition or disease |
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HIV Infections |
Primary Objective:
To collect and evaluate long-term clinical outcomes of HIV infected participants previously enrolled in HIV-NAT trials.
Secondary Objective:
To Assess:
- Long-term consequences of initiation of antiretroviral as predicted by baseline CD4 cell count and/or baseline plasma HIV RNA level
- 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
- Class-specific incidence of lipodystrophy and metabolic complications such as d4T versus AZT, nevirapine versus efavirenz and individual PIs (IDV, SQV, Kaletra, and atazanavir)
- Resistance profiles in patients on different antiretroviral regimens
- Long-term consequences of antiretroviral agents on cardiovascular, renal, hepatic, and endocrine function, skin, gastrointestinal system and urogentital tract
- Incidence of opportunistic infections or malignancy including hepatocarcinoma in patients with HIV/HCV or HIV/HBV co-infection
- Immune recovery syndrome
- Adherence to different antiretroviral regimens
- Quality of life
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 |
Study Start Date : | November 2002 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00411983
Contact: Anchalee Avihingsanon, MD, PhD | 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 | |
HIV-NAT, Thai Red Cross AIDS Research Center | Recruiting |
Bangkok, Thailand, 10330 | |
Principal Investigator: Praphan Phanuphak, MD, PhD |
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT00411983 History of Changes |
Other Study ID Numbers: |
HIV-NAT 006 |
First Posted: | December 15, 2006 Key Record Dates |
Last Update Posted: | February 24, 2017 |
Last Verified: | February 2017 |
Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
chronic HIV infection long term cohort of HIV infection |
Additional relevant MeSH terms:
Infection 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 |