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Effects of Anti-HIV Therapy on Nervous System Function

16. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

297

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change in QNPZ-5 scores
time to development of symptomatic peripheral neuropathy
change in peripheral neuropathy symptoms

Sekundære resultatmål

Resultatmål
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Efterforskere

  • Studiestol: Edwina Wright, MBBS, FRACP, Infectious Disease Unit, the Alfred Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2005

Primær færdiggørelse (Faktiske)

1. juli 2007

Studieafslutning (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først indsendt

5. februar 2007

Først indsendt, der opfyldte QC-kriterier

5. februar 2007

Først opslået (Skøn)

6. februar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CPCRA 065F
  • CPCRA 065
  • CPCRA 065F1
  • 10115 (DAIDS-ES)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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