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A Study of HIV-Disease Development in Aging

28. oktober 2021 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase II Exploratory Study Examining Immunologic and Virologic Indices in Two Age-Differentiated Cohorts of HIV-Infected Subjects to Explore the Basis of Accelerated HIV-Disease Progression Associated With Aging

The purpose of this study is to better understand the relationship between age and HIV disease progression.

This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.

Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 [AS PER AMENDMENT 06/04/02: 192] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 [AS PER AMENDMENT 06/04/02: Week 192]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s [AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.]

Undersøgelsestype

Interventionel

Tilmelding

90

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 900331079
        • USC CRS
      • Palo Alto, California, Forenede Stater, 943055107
        • Stanford CRS
      • San Francisco, California, Forenede Stater, 941102859
        • Ucsf Aids Crs
      • San Jose, California, Forenede Stater, 951282699
        • Santa Clara Valley Med. Ctr.
      • San Mateo, California, Forenede Stater, 943055107
        • San Mateo County AIDS Program
      • San Rafael, California, Forenede Stater, 94903
        • Marin County Dept. of Health & Human Services, HIV/AIDS Program & Specialty Clinic
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80262
        • University of Colorado Hospital CRS
    • Florida
      • Miami, Florida, Forenede Stater, 331361013
        • Univ. of Miami AIDS CRS
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
      • Honolulu, Hawaii, Forenede Stater, 96816
        • Queens Med. Ctr.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University CRS
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Methodist Hosp. of Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana Univ. School of Medicine, Wishard Memorial
      • Indianapolis, Indiana, Forenede Stater, 462025250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, Forenede Stater, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, Forenede Stater, 02215
        • Brigham and Women's Hosp. ACTG CRS
      • Boston, Massachusetts, Forenede Stater
        • Beth Israel Deaconess Med. Ctr., ACTG CRS
      • Fall River, Massachusetts, Forenede Stater
        • SSTAR, Family Healthcare Ctr.
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota, ACTU
    • Missouri
      • Saint Louis, Missouri, Forenede Stater
        • Washington U CRS
    • New York
      • New York, New York, Forenede Stater, 10003
        • Beth Israel Med. Ctr., ACTU
      • New York, New York, Forenede Stater, 10016
        • NY Univ. HIV/AIDS CRS
      • New York, New York, Forenede Stater, 10029
        • Mt. Sinai Med. Ctr. A0404 CRS
      • New York, New York, Forenede Stater
        • Columbia Univ., HIV Prevention and Treatment Medical Ctr.
      • New York, New York, Forenede Stater
        • Mt.Sinai Med. Ctr. A1009 CRS
      • Rochester, New York, Forenede Stater, 14642
        • Univ. of Rochester ACTG CRS
      • Rochester, New York, Forenede Stater, 14642
        • AIDS Care CRS
      • Rochester, New York, Forenede Stater, 14607
        • Trillium Health ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 275997215
        • Unc Aids Crs
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Univ. Med. Ctr. Adult CRS
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case CRS
      • Cleveland, Ohio, Forenede Stater, 441091998
        • MetroHealth CRS
      • Columbus, Ohio, Forenede Stater, 432101228
        • The Ohio State University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Philadelphia Veterans Admin. Med. Ctr. A6205 CRS
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • The Miriam Hosp. ACTG CRS
      • Providence, Rhode Island, Forenede Stater
        • Rhode Island Hosp.
    • Tennessee
      • Nashville, Tennessee, Forenede Stater
        • Vanderbilt Therapeutics CRS
    • Texas
      • Dallas, Texas, Forenede Stater, 75235-9173
        • Univ. of Texas Southwestern Med. Ctr., Amelia Court Continuity Clinic
      • Galveston, Texas, Forenede Stater, 77555-0435
        • Univ. of Texas Medical Branch, ACTU
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • University of Washington AIDS CRS
  • Puerto Rico
      • San Juan, Puerto Rico, 009365067
        • Puerto Rico-AIDS 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

13 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
  • Have a viral load of more than 2000 copies/ml within 60 days of study entry.
  • Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
  • Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Are pregnant or breast-feeding.
  • Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
  • Have hepatitis within 30 days of study entry.
  • Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
  • Are receiving chemotherapy or radiation treatment.
  • Have taken antiretroviral drugs for more than 14 days.
  • Have received an HIV vaccine within 30 days of study.
  • Have a serious illness or infection within 14 days of the study.
  • Have other serious conditions that might interfere with study participation.
  • Have taken or plan to take certain other drugs that might affect the study results.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

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: Robert Kalayjian

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

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. oktober 2000

Studieafslutning (Faktiske)

1. april 2005

Datoer for studieregistrering

Først indsendt

7. august 2000

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. oktober 2021

Sidst verificeret

1. oktober 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5015
  • 10168 (Registry Identifier: DAIDS ES)
  • ACTG A5015
  • AACTG A5015
  • Substudy ACTG A5016s
  • Substudy ACTG A5020s

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 .

Abonner