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Effects of Anti-HIV Therapy on Nervous System Function

16. april 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

297

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Coenrollment in the SMART study

Exclusion Criteria:

  • Unable to comply with all study requirements

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2005

Primær fullføring (Faktiske)

1. juli 2007

Studiet fullført (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først innsendt

5. februar 2007

Først innsendt som oppfylte QC-kriteriene

5. februar 2007

Først lagt ut (Anslag)

6. februar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

17. april 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2014

Sist bekreftet

1. april 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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