Search / Trial NCT00001024

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Didanosine Aids Related Complex Zidovudine Lymph Nodes Lymphoid Tissue

Description

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 ...

Gender

All

Eligibility criteria

  • 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).

Attachments

readout_NCT00001024_2024-07-14.pdf

4.5 MB

NCT00001024_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Durham, North Carolina, United States

Pittsburgh, Pennsylvania, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Palo Alto, California, United States

San Francisco, California, United States

Stony Brook, New York, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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