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Effects of Anti-HIV Therapy on Nervous System Function

16 avril 2014 mis à jour par: National Institute of Allergy and Infectious Diseases (NIAID)

Neurology: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (SMART) to Determine the Impact of the Strategies Upon Central and Peripheral Nervous System Function

The purpose of this study is to observe the way two different anti-HIV treatment strategies affect nerve and brain function in adults with HIV.

Aperçu de l'étude

Statut

Complété

Les conditions

Infections à VIH

Description détaillée

AIDS dementia complex (ADC) is a condition characterized by cognitive impairment, psychomotor slowing, and behavioral change. A milder form of ADC, called HIV minor cognitive/motor disorder (MCMD), is characterized by similar symptoms but has less of an impact on daily functioning. The neurocognitive impairment that results from ADC and MCMD carries an increased risk of poor drug adherence, morbidity, and mortality. It is unclear if highly active antiretroviral therapy (HAART) is effective in preserving neurocognitive function or in preventing or treating neurocognitive impairment. Distal symmetric sensory polyneuropathy (DSPN) and nucleoside-related neuropathy are two other serious conditions that HIV patients are at high risk for. DSPN is thought to be caused by active HIV infection; nucleoside-related neuropathy is thought to be caused by mitochondrial toxicity related to the use of certain antiretrovirals. These 2 conditions may lead to severe pain and discomfort in the feet. It is unknown what connection, if any, there is between DSPN and nucleoside-related neuropathy and the use of HAART. More data are needed on the natural history of these conditions.

This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. The purpose of this study is to compare changes in neurocognitive functioning and peripheral neuropathy symptoms between the 2 strategies of the SMART study.

Patients will participate in this substudy and the main SMART study at the same time. Within 45 days prior to randomization into the main SMART study, participants will have baseline data collected for this substudy. This data will include peripheral neuropathy assessments, treatments for symptoms of peripheral neuropathy. At selected study sites, additional measures will assess neurocognitive function, depression, alcohol and drug use, and education. At 6 months, 12 months, and every 12 months thereafter, peripheral neuropathy symptoms and treatment for the symptoms will be assessed; a pain questionnaire will also be completed. Participants will be followed until the SMART study ends.

Type d'étude

Observationnel

Inscription (Réel)

297

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Australie
- New South Wales
  - Burwood, New South Wales, Australie, 2134
    - Burwood Road Gen. Practice CRS
  - Darlinghurst, New South Wales, Australie, 2010
    - St. Vincent's Hospital CRS
  - Westmead, New South Wales, Australie, 2145
    - Westmead Hospital CRS
- Victoria
  - Carlton,, Victoria, Australie
    - Melbourne Sexual Health Ctr. CRS
  - Melbourne, Victoria, Australie, 3004
    - The Alfred Hosp., Clinical Research - Infectious Diseases Unit CRS
  - Melbourne, Victoria, Australie, 3181
    - Prahran Market Clinic CRS
Brésil
- - Sao Paulo, Brésil, 01246-900
    - Instituto de Infectologia Emilio Ribas CRS
- Bahia
  - Salvador, Bahia, Brésil, 40110-160
    - Hosp. Universitario Prof. Edgard SantosCRS
Canada
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Q.E. II Health Sciences Ctr., Captial District Authority, Victoria Gen. Hosp. CRS
- Ontario
  - Windsor, Ontario, Canada, N8W 1E3
    - Windsor Regional Hosp., HIV Care Program CRS
Thaïlande
- - Chiang Mai, Thaïlande
    - Sanpatong Hosp. CRS
  - Khon Kaen, Thaïlande, 40002
    - Khon Kaen Univ., Srinagarind Hosp., Div. of Infectious Diseases & Tropical Medicine, Dept. of Medici
- Nonthaburi
  - Muang, Nonthaburi, Thaïlande
    - Bamrasnaradura Institute CRS
- Ratchathewi
  - Bangkok, Ratchathewi, Thaïlande
    - Chulalongkorn University Hospital CRS
  - Bangkok, Ratchathewi, Thaïlande
    - Mahidol Univ., Ramathibodi Hosp., Div of Infectious Disease CRS
États-Unis
- California
  - San Francisco, California, États-Unis, 94114
    - Castro-Mission Health Ctr. CRS
- Colorado
  - Denver, Colorado, États-Unis, 80204-4507
    - Univ. of Colorado Health Science Ctr. CRS
  - Denver, Colorado, États-Unis, 80205
    - Eastside Family Health Ctr. CRS
  - Denver, Colorado, États-Unis, 80204
    - Denver Public Health CRS
  - Denver, Colorado, États-Unis, 80204-4507
    - Kaiser Permanente of Denver CRS
  - Wheat Ridge, Colorado, États-Unis, 80033
    - Western Infectious Disease Consultants CRS
- District of Columbia
  - Washington, District of Columbia, États-Unis, 20422
    - Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
- Florida
  - Jacksonville, Florida, États-Unis, 32206
    - Univ. of Florida, Div. of Infectious Diseases CRS
- Louisiana
  - Baton Rouge, Louisiana, États-Unis, 70805
    - Earl K. Long Med. Ctr., LSU - Mid City EIC Clinic CRS
- Michigan
  - Detroit, Michigan, États-Unis, 48202
    - Henry Ford Hosp. CRS
  - Detroit, Michigan, États-Unis, 48201
    - Wayne State Univ. CRS
  - Lansing, Michigan, États-Unis, 48910
    - Michigan State Univ., Infectious Disease Clinic CRS
- New York
  - Bronx, New York, États-Unis, 10457
    - Bronx-Lebanon Hosp. Ctr. CRS
  - Bronx, New York, États-Unis, 10461
    - Jacobi Med. Ctr., Ambulatory Care Pavillion CRS
  - Bronx, New York, États-Unis, 10467
    - Montefiore Med. Ctr., AIDS Ctr. CRS
  - Bronx, New York, États-Unis, 10468
    - Bronx VAMC CRS
  - Brooklyn, New York, États-Unis, 11203
    - SUNY Downstate Med. Ctr., HIV Ctr. for Women & Children CRS
  - New York, New York, États-Unis, 10037-1802
    - Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
- Oklahoma
  - Oklahoma City, Oklahoma, États-Unis, 73104
    - Univ. of Oklahoma Health Sciences Ctr., Div. of Infectious Diseases CRS
- Oregon
  - Portland, Oregon, États-Unis, 97227
    - Kaiser Immune Deficiency Clinic of Portland CRS
  - Portland, Oregon, États-Unis, 97239
    - Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
  - Portland, Oregon, États-Unis, 97210
    - The Research & Education Group-Portland CRS
  - Portland, Oregon, États-Unis, 97227
    - Legacy Clinic Emanuel CRS
- Pennsylvania
  - Philadelphia, Pennsylvania, États-Unis, 19140
    - Temple Univ. School of Medicine CRS
- Virginia
  - Fredericksburg, Virginia, États-Unis, 22401
    - MediCorp, Infectious Disease Associates CRS
  - Richmond, Virginia, États-Unis, 23298
    - Virginia Commonwealth Univ. Medical Ctr. CRS
  - Richmond, Virginia, États-Unis, 23224
    - CrossOver Health Ctr. CRS
  - Richmond, Virginia, États-Unis, 23298
    - VCU Health Systems, Infectious Disease Clinic CRS
  - Richmond, Virginia, États-Unis, 23223
    - Vernon Harris East End Community Health Ctr. CRS
- Wisconsin
  - Milwaukee, Wisconsin, États-Unis, 53226
    - Med. College of Wisconsin, Infectious Disease Clinic CRS

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

Coenrollment in the SMART study

Exclusion Criteria:

Unable to comply with all study requirements

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Change in QNPZ-5 scores
time to development of symptomatic peripheral neuropathy
change in peripheral neuropathy symptoms

Mesures de résultats secondaires

Mesure des résultats
Time to neurocognitive impairment
time to development of ADC, stage 2 or greater
chage in peripheral neuropathy symptoms
time to development of asymptomatic or symptomatic peripheral neuropathy
time to resolution of symptomatic peripheral neuropathy

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

Chaise d'étude: Edwina Wright, MBBS, FRACP, Infectious Disease Unit, the Alfred Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Click here for information on CPCRA 065

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 2005

Achèvement primaire (Réel)

1 juillet 2007

Achèvement de l'étude (Réel)