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Recruiting

NCT Number: NCT00411983

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HIV-NAT, Thai Red Cross AIDS Research Center

Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Praphan Phanuphak, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Anchalee Avihingsanon, MD, PhD

CONTACT

[email protected]

66 2 2557334-5 ext. 107

Stephen Kerr, PhD

CONTACT

[email protected]

66 2 2557334-5 ext. 138

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2030
Study completion
2030
First posted
Dec 15, 2006
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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