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Screening HIV-Infected Patients for Vaccine Studies

30 juni 2017 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

Screening HIV-Infected Subjects for Vaccine Research Studies

This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive).

  • Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis.
  • Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases.
  • Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present.

HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate.

Participants will be screened with the following:

  • A health history, including questions about sexual activity and drug use;
  • Physical examination, including blood and urine tests;
  • HIV testing to confirm HIV infection;
  • Pregnancy test for premenopausal women;
  • PPD test for tuberculosis for those who have not been tested in the previous 6 months.

Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

Study Design: The purpose of this protocol is to screen potential study volunteers with HIV infection to determine if they are suitable candidates for vaccine trials. Screening will be primarily for HIV vaccine trials, but may also be for screening HIV-infected adults to participate in trials of other kinds of vaccine studies that will be enrolling HIV-infected subjects. All work will be conducted at the National Institutes of Health. HIV-infected volunteers will be recruited and screened. This protocol will be used to determine if the volunteers meet eligibility requirements for participation in trials of vaccines in HIV-infected subjects.

Subjects: Approximately 1,000 adults with HIV infection.

Study Plan: Subjects are evaluated for eligibility to participate in a vaccine trial and receive counseling on HIV-related issues. Women receive counseling on avoidance of pregnancy during a clinical trial. If it is determined that the volunteer might be eligible for a vaccine trial, additional information about trial options will be provided by telephone, mail and/or visits with a study coordinator.

Study Duration: Approximately six months for each subject.

Study Evaluations: Evaluations usually include history and physical examinations and CBC, differential, platelets, PT/PTT, chemistry panel, urinalysis, pregnancy test for women of reproductive potential, hepatitis B surface antigen, hepatitis C antibody, RPR, ELISA and Western blot for HIV, anti-dsDNA, quantitative immunoglobulins, adenovirus serology and T cell subsets (CD4/CD8). However, only those evaluations needed to determine eligibility for a particular vaccine study will be completed. Blood will also be collected for storage. If needed for eligibility in a particular vaccine study, a PPD will be administered unless subject has documentation of a negative PPD within six months prior to enrollment. In addition, other standard clinical evaluations may be done if needed to determine eligibility for a particular vaccine study.

Studietype

Observationeel

Inschrijving

1000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Maryland
      • Bethesda, Maryland, Verenigde Staten, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

  • INCLUSION CRITERIA:

Age 18 years or older

HIV-infected, confirmed by ELISA and Western blot

Willing to participate for the planned duration of the study (6 months or longer)

Able and willing to give informed consent

Agree to have blood stored for future studies related to HIV, the immune system, vaccine response and/or other medical conditions

EXCLUSION CRITERIA:

Women who are known to be pregnant or breast feeding

Clinically significant medical history, physical examination or laboratory test results that preclude participation in a clinical trial.

A condition requiring medication that affects the immune response to a vaccine such as oral and parenteral corticosteroids, hydroxyurea, interleukin-2 or other immune modulators.

A condition in which repeated blood draws or injections poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.

A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being

A condition in which signs or symptoms could be confused with reactions to vaccine

Active participation in other experimental treatment studies

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

9 januari 2003

Primaire voltooiing (Werkelijk)

1 december 2007

Studie voltooiing (Werkelijk)

1 december 2007

Studieregistratiedata

Eerst ingediend

10 januari 2003

Eerst ingediend dat voldeed aan de QC-criteria

10 januari 2003

Eerst geplaatst (Schatting)

13 januari 2003

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2017

Laatst geverifieerd

25 juni 2009

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 030079
  • 03-I-0079

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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