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A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1

11. september 2008 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Evaluation of Virologic, Immunologic, and Clinical Parameters of Participants in HIVNET 014 Who Become Infected With HIV-1

The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Patients who receive HIV vaccines are sometimes protected from HIV infection. More often, these patients become HIV-positive but experience a boost in their immune system that helps their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection in order to develop new HIV vaccines and other treatments for HIV and AIDS.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

There are many possible outcomes of HIV-1 infection among persons who receive experimental HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing immunity). However, current viral vaccines are thought to limit, but not prevent, virus replication after infection. In the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. Understanding the evolution of the immune response in vaccinees after subsequent exposure and HIV infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1 infection.

Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are enrolled in this study. Participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. Study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.

Undersøgelsestype

Observationel

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94102
        • San Francisco Dept of Hlth / AIDS Office
    • Colorado
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Dept of Public Health / HIVNET
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Univ of Illinois Chicago / Howard Brown Hlth Ctr
      • Chicago, Illinois, Forenede Stater, 60657
        • Howard Brown Health Ctr / HIVNET
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Fenway Community Health Ctr / HIVNET
    • New York
      • Bronx, New York, Forenede Stater, 10456
        • New York Blood Ctr
      • New York, New York, Forenede Stater, 10016
        • New York Univ Med Ctr
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Univ of Pennsylvania / HIVNET
    • Rhode Island
      • Pawtucket, Rhode Island, Forenede Stater, 02860
        • Mem Hosp of Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Miriam Hosp
    • Washington
      • Seattle, Washington, Forenede Stater, 98104
        • Univ of Washington

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 til 60 år (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:

  • Become infected with HIV while participating in HIVNET 014, or if they are an HIV-positive partner (sexual or needle-sharing) of a HIVNET 014A participant.
  • Are able and willing to provide written informed consent.

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have a serious psychiatric or psychological disorder that would prevent them from completing the study.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

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: Connie Celum
  • Studiestol: Susan Buchbinder
  • Studiestol: Haynes Sheppard

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. august 1999

Datoer for studieregistrering

Først indsendt

2. november 1999

Først indsendt, der opfyldte QC-kriterier

30. august 2001

Først opslået (Skøn)

31. august 2001

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. september 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2008

Sidst verificeret

1. juni 2003

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HIVNET 014A

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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