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The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS

28 oktober 2021 bijgewerkt door: National Institute of Allergy and Infectious Diseases (NIAID)

A Multicenter, Open-Label Study of Viral Burden in Peripheral Blood Versus Lymphoid Tissue Before and After Antiretroviral Therapy in HIV-Infected Individuals Without AIDS (NOTE: One Arm Receives no Treatment)

Immunopathogenesis objectives: To compare and quantitatively determine HIV burden and HIV replication in peripheral blood (PB) and lymphoid tissue (LT). To determine the degree to which antiretroviral therapy alters HIV replication in LT.

Clinical objectives: To gain insight into the degree of correlation between immunologic surrogate markers for HIV disease (e.g., CD4, beta-2 microglobulin) as compared to measures of HIV replication in PB and LT. To assess changes in PB and LT viral burden after antiretroviral therapy and to determine its ability to predict an antiviral response.

One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

One of the major problems in defining the immunopathogenic changes in HIV infections has been the inability to correlate the extent of loss of immunologic function with the number of HIV-infected CD4+ cells in the peripheral blood. Few studies exist that measure viral burden in lymph nodes of HIV-infected individuals. Researchers hope to find out whether the amount of HIV virus or markers for the virus in the body's lymph tissue is a better measure of disease progression than the amount of virus or markers for the virus in the blood.

Sixteen antiretroviral-naive patients are randomized to either remain antiretroviral-naive (no treatment) or receive zidovudine daily (treatment). Additionally, 16 patients with 26 or more weeks of ongoing zidovudine (AZT) therapy are randomized to either continue on their prestudy AZT regimen or add didanosine (ddI) daily to their baseline AZT dose. Patients remain on their assigned treatment arms for 8 weeks. A lymph node biopsy is performed on day 0 and at week 8. Patients are evaluated at weeks 2, 4, 6, 8 and 9.

Studietype

Ingrijpend

Inschrijving

32

Fase

  • Niet toepasbaar

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
    • California
      • Palo Alto, California, Verenigde Staten, 94304
        • Palo Alto Veterans Affairs Health Care System
      • San Francisco, California, Verenigde Staten, 94115
        • Kaiser Permanente Med Ctr
      • San Francisco, California, Verenigde Staten, 94115
        • Mount Zion Med Ctr / UCSF
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Univ of Illinois
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21201
        • Univ of Maryland at Baltimore
    • New York
      • Stony Brook, New York, Verenigde Staten, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27710
        • Duke Univ Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15261
        • Univ of Pittsburgh

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

Concurrent Medication:

Allowed:

  • Chemoprophylaxis against M. tuberculosis, therapy for oral candidiasis, and short courses (up to 10 days) of acyclovir for herpes lesions.
  • Antibiotics as clinically indicated.
  • Pneumococcal vaccine and hepatitis B vaccine as medically indicated.
  • Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, or other medications deemed appropriate by the patient's primary care provider.

Recommended:

  • PCP prophylaxis if patient's CD4 count falls below 200 cells/mm3 during the study.

Concurrent Treatment:

Allowed:

  • Alternative therapies such as vitamins and acupuncture.

Patients must have:

  • Documented HIV infection.
  • At least two palpable lymph nodes above the waist.
  • CD4 counts >= 350 cells/mm3 (if previously antiretroviral-naive) or >= 250 cells/mm3 (if receiving ongoing AZT therapy).

Patients with prior AZT therapy must have received a stable dose of 300-600 mg daily for 26 or more weeks.

Prior Medication:

Required in patients with prior ongoing therapy:

  • AZT at dose of 300-600 mg daily for at least 26 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Severe malabsorption.
  • Current AIDS-related opportunistic infection, AIDS dementia, AIDS-wasting syndrome, or an AIDS-related malignancy other than minimal Kaposi's sarcoma disease.
  • Current medical problems that may interfere with the evaluation of AZT or increase the potential toxicity of AZT (e.g., significant liver disease, diabetes, significant cardiovascular disease, seizure disorders, lymphoma, acute or chronic pancreatitis, or febrile illness).
  • Current diagnosis of malignancy for which systemic therapy would be required during study.

Concurrent Medication:

Excluded:

  • Ganciclovir, foscarnet, chronic acyclovir, or probenecid.
  • Other proven or alleged antiretroviral or anti-HIV drugs.
  • Biologic response modifiers.
  • Valproic acid.
  • Systemic cytotoxic chemotherapy.
  • Steroids.

Concurrent Treatment:

Excluded:

  • Radiation therapy.

Patients with the following prior conditions are excluded:

  • Prior AIDS-related opportunistic infection, AIDS dementia, AIDS-wasting syndrome, or an AIDS-related malignancy other than minimal Kaposi's sarcoma disease.
  • History of medical problems that may interfere with the evaluation of AZT or increase the potential toxicity of AZT (e.g., significant liver disease, diabetes, significant cardiovascular disease, seizure disorders, lymphoma, acute or chronic pancreatitis, or febrile illness).
  • History of peripheral neuropathy (patients with prior AZT treatment only).

Prior Medication:

Excluded:

  • Prior ddI therapy.
  • Less than 26 weeks of prior AZT (in patients with ongoing AZT therapy only).
  • Ganciclovir, foscarnet, chronic acyclovir, or probenecid.
  • Cytotoxic chemotherapy within 1 month prior to study entry.
  • Acute therapy for an infection or other medical illness within 14 days prior to study entry.

History of alcohol abuse (patients with prior AZT treatment).

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?

Ontwerpdetails

  • Primair doel: Behandeling

Medewerkers en onderzoekers

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Medewerkers

Bristol-Myers Squibb
Glaxo Wellcome

Onderzoekers

  • Studie stoel: M Niu
  • Studie stoel: J Cohn

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

  • Cohen OJ, Pantaleo G, Graziosi C, Niu M, Fauci AS. Effect of antiretroviral therapy on HIV burden and replication in lymphoid tissue. DATRI 003 Study Group. Int Conf AIDS. 1994 Aug 7-12;10(1):7 (abstract no 001B)

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 voltooiing (Werkelijk)

1 juni 2002

Studieregistratiedata

Eerst ingediend

2 november 1999

Eerst ingediend dat voldeed aan de QC-criteria

30 augustus 2001

Eerst geplaatst (Schatting)

31 augustus 2001

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 november 2021

Laatste update ingediend die voldeed aan QC-criteria

28 oktober 2021

Laatst geverifieerd

1 oktober 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DATRI 003
  • 11734 (Register-ID: DAIDS ES Registry Number)

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