A Long-term Follow-up of the HIV-NAT Cohort - Full Text View

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:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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:

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

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:

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) This link exits the ClinicalTrials.gov site

Publications:

Kerr SJ, Duncombe C, Avihingsanon A, Ananworanich J, Boyd M, Sopa B, Medtech B, Chuenyam T, Cooper DA, Lange JM, Phanuphak P, Ruxrungtham K. Dyslipidemia in an Asian population after treatment for two years with protease inhibitor-containing regimens. J Int Assoc Physicians AIDS Care (Chic). 2007 Mar;6(1):36-46.

Avihingsanon A, Avihingsanon Y, Darnpornprasert P, Kerr S, Ungsedhapand C, Duncombe C, Ubolyam S, Ruxrungtham K, Phanuphak P. High prevalence of indinavir-associated renal complications in Thai HIV-infected patients. J Med Assoc Thai. 2006 Aug;89 Suppl 2:S21-7.

Nuesch R, Srasuebkul P, Ananworanich J, Ruxrungtham K, Phanuphak P, Duncombe C; HIV-NAT Study Team. Monitoring the toxicity of antiretroviral therapy in resource limited settings: a prospective clinical trial cohort in Thailand. J Antimicrob Chemother. 2006 Sep;58(3):637-44.

Boyd MA, Srasuebkul P, Khongphattanayothin M, Ruxrungtham K, Hassink EA, Duncombe CJ, Ubolyam S, Burger DM, Reiss P, Stek M Jr, Lange J, Cooper DA, Phanuphak P. Boosted versus unboosted indinavir with zidovudine and lamivudine in nucleoside pre-treated patients: a randomized, open-label trial with 112 weeks of follow-up (HIV-NAT 005). Antivir Ther. 2006;11(2):223-32.

Boyd MA, Siangphoe U, Ruxrungtham K, Duncombe CJ, Stek M, Lange JM, Cooper DA, Phanuphak P. Indinavir/ritonavir 800/100 mg bid and efavirenz 600 mg qd in patients failing treatment with combination nucleoside reverse transcriptase inhibitors: 96-week outcomes of HIV-NAT 009. HIV Med. 2005 Nov;6(6):410-20.

Pace C, Emanuel EJ, Chuenyam T, Duncombe C, Bebchuk JD, Wendler D, Tavel JA, McNay LA, Phanuphak P, Forster HP, Grady C. The quality of informed consent in a clinical research study in Thailand. IRB. 2005 Jan-Feb;27(1):9-17.

Ananworanich J, Moor Z, Siangphoe U, Chan J, Cardiello P, Duncombe C, Phanuphak P, Ruxrungtham K, Lange J, Cooper DA. Incidence and risk factors for rash in Thai patients randomized to regimens with nevirapine, efavirenz or both drugs. AIDS. 2005 Jan 28;19(2):185-92.

Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S, Lange JM, Phanuphak P, Cooper DA. HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS. 2005 Jan 28;19(2):169-78.

Law WP, Duncombe CJ, Mahanontharit A, Boyd MA, Ruxrungtham K, Lange JM, Phanuphak P, Cooper DA, Dore GJ. Impact of viral hepatitis co-infection on response to antiretroviral therapy and HIV disease progression in the HIV-NAT cohort. AIDS. 2004 May 21;18(8):1169-77.

Law WP, Dore GJ, Duncombe CJ, Mahanontharit A, Boyd MA, Ruxrungtham K, Lange JM, Phanuphak P, Cooper DA. Risk of severe hepatotoxicity associated with antiretroviral therapy in the HIV-NAT Cohort, Thailand, 1996-2001. AIDS. 2003 Oct 17;17(15):2191-9.


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:


HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections	Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015