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The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS Clinical research trials and The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS. The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS  The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Bristol-Myers Squibb,Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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).
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
JCohn, Study Chair,
Mount Zion Med Ctr / UCSF
San Francisco, California, 94115
United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304
United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261
United States
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
United States
Univ of Illinois
Chicago, Illinois, 60612
United States
Univ of Maryland at Baltimore
Baltimore, Maryland, 21201
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: DATRI 003;
Study Start Date:
Record last reviewed: November 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001024
Other Hiv Infections Studies:
1. Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
2. A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination with Zidovudine (ZDV) versus ZDV alone in HIV-1 Infected Individuals with CD4 Counts of 200-500mm3
3. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
4. A Study of Tumor Necrosis Factor and Human Interferon-gamma in Patients with AIDS Related Complex
5. A Study of Patients with AIDS Syndrome
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
The Effects of Anti-HIV Drugs in HIV-Infected Patients Who Do Not Have AIDS
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