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

HIV Infections Clinical Trial

Official title:

A Long-term Follow-up Study for HIV-infected Individuals Who Have Participated in HIV-NAT Study Protocols

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00411983
• Other study ID #: HIV-NAT 006
• Status: Recruiting
• Start date: November 2002
• Est. completion date: December 2030

Study information

• Verified date: February 2024
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: Anchalee Avihingsanon, MD, PhD
• Phone: 66 2 2557334-5
• Email: anchalee.a[@]hivnat.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections

Locations

Country	Name	City	State
Thailand	HIV-NAT, Thai Red Cross AIDS Research Center	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration

Country where clinical trial is conducted

Thailand, 

References & Publications (14)

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: — View Citation

Avihingsanon A, Jitmitraparp S, Tangkijvanich P, Ramautarsing RA, Apornpong T, Jirajariyavej S, Putcharoen O, Treeprasertsuk S, Akkarathamrongsin S, Poovorawan Y, Matthews GV, Lange JM, Ruxrungtham K; HIV-NAT125 study team. Advanced liver fibrosis by tran — View Citation

Avihingsanon A, Kerr SJ, Punyawudho B, van der Lugt J, Gorowara M, Ananworanich J, Lange JM, Cooper DA, Phanuphak P, Burger DM, Ruxrungtham K. Short communication: Aging not gender is associated with high atazanavir plasma concentrations in Asian HIV-infe — View Citation

Avihingsanon A, Ramautarsing RA, Suwanpimolkul G, Chetchotisakd P, Bowonwatanuwong C, Jirajariyavej S, Kantipong P, Tantipong H, Ohata JP, Suankratay C, Ruxrungtham K, Burger DM. Ergotism in Thailand caused by increased access to antiretroviral drugs: a g — View Citation

Avihingsanon A, Tongkobpetch S, Kerr SJ, Punyawudho B, Suphapeetiporn K, Gorowara M, Ruxrungtham K, Shotelersuk V. Pharmacogenetic testing can identify patients taking atazanavir at risk for hyperbilirubinemia. J Acquir Immune Defic Syndr. 2015 May 1;69(1 — View Citation

Clarke A, Kerr S, Honeybrook A, Cooper DA, Avihingsanon A, Duncombe C, Phanuphak P, Ruxrungtham K, Ananworanich J, Kaldor J. Adherence and Risk Behaviour in Patients with HIV Infection Receiving Antiretroviral Therapy in Bangkok. Open Virol J. 2012;6:23-8 — View Citation

Durier N, Ananworanich J, Apornpong T, Ubolyam S, Kerr SJ, Mahanontharit A, Ferradini L, Ruxrungtham K, Avihingsanon A. Cytomegalovirus viremia in Thai HIV-infected patients on antiretroviral therapy: prevalence and associated mortality. Clin Infect Dis. — View Citation

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 I — View Citation

Kerr SJ, Punyawudho B, Thammajaruk N, Colbers A, Chaiyahong P, Phonphithak S, Sapsirisavat V, Ruxrungtham K, Burger DM, Avihingsanon A. Factors associated with daily tenofovir exposure in Thai subjects taking combination antiretroviral therapy. AIDS Res H — View Citation

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. doi: — View Citation

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 — View Citation

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. 20 — View Citation

Praditpornsilpa K, Avihingsanon A, Chaiwatanarat T, Chaiyahong P, Wongsabut J, Ubolyam S, Chulakadabba A, Avihingsanon Y, Ruxrungtham K, Tunsanga K, Eiam-Ong S, Phanuphak P. Comparisons between validated estimated glomerular filtration rate equations and — View Citation

Wattanakul T, Avihingsanon A, Manosuthi W, Punyawudho B. Population pharmacokinetics of nevirapine in Thai HIV-infected patients. Antivir Ther. 2014;19(7):651-60. doi: 10.3851/IMP2741. Epub 2014 Feb 6. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV infection	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	30 years

External Links

•   The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)