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A Phase I Study of Methotrexate for HIV Infection Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Phase I Study of Methotrexate for HIV Infection conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase I Study of Methotrexate for HIV Infection Clinical research trials and A Phase I Study of Methotrexate for HIV Infection medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Phase I Study of Methotrexate for HIV Infection. A Phase I Study of Methotrexate for HIV Infection Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase I Study of Methotrexate for HIV Infection clinical trial. Participants oftentimes recieve the finest healthcare available for their A Phase I Study of Methotrexate for HIV Infection condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Methotrexate for HIV Infection  A Phase I Study of Methotrexate for HIV Infection
A Phase I Study of Methotrexate for HIV Infection
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.
Details: In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation. Patients are randomized to receive methotrexate at Dose 1 or 2 (low doses) for 12 weeks, with 8 weeks of follow-up. If interim safety monitoring and viral burden results for the two cohorts support continuation, a third cohort of patients receive methotrexate starting at Dose 2 for the first 2 weeks, then at Dose 3 for the next 2 weeks, and at Dose 4 for the remaining 8 weeks, with 8 weeks of follow-up. AS PER AMENDMENT 1/10/97: The Dose 1 (the lowest dose) has been eliminated; the first 10 patients are now assigned to the next higher dose. Depending upon the results of interim safety data, the next cohort will be entered on the escalating dose regimen. Also per this amendment, all patients will receive zidovudine and lamivudine for 30 days prior to the initiation of methotrexate, during the 12 weeks of methotrexate administration, and for the 8 weeks of follow-up.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Antiemetics and antidiarrheals. - Acetaminophen. - Oral hypoglycemic agents. PER AMENDMENT 5/15/96: - Stable dose of antiretroviral (must be stable for at least 1 month prior to study entry). [AS PER AMENDMENT 1/10/97: - Combination zidovudine/lamivudine or zidovudine alone.] Patients must have: - HIV seropositivity. - CD4 count >= 300 cells/mm3. - No AIDS-defining condition. Exclusion Criteria Co-existing Condition: Patients with the following symptom or condition are excluded: - Current positive PPD. Concurrent Medication: Excluded: - Immunosuppressive or immunomodulatory drugs. - Chronic nonsteroidal anti-inflammatory agents. - Newly initiated antiretrovirals. - Bone marrow suppressive drugs (e.g., TMP/SMX). Concurrent Treatment: AS PER AMENDMENT 1/10/97: Excluded: - Antiretroviral therapy other than combination zidovudine/lamivudine or zidovudine alone; no initiation of other antiretroviral therapy should be planned while patient is on methotrexate. Patients with the following prior conditions are excluded: - Prior malignancies. - Prior mucocutaneous herpes infection requiring antiviral therapy [AS PER AMENDMENT 7/31/96: Prior mucocutaneous herpes infection requiring systemic treatment with an antiviral agent (e.g., acyclovir); history of topical antiviral therapy is permitted]. - Anergic on DTH skin test within the past month (PER AMENDMENT 5/15/96: patients who are positive on DTH skin test but unable to receive the HIV-1 skin test because of allergies to insects, bee stings, etc., remain eligible for study enrollment). - Inflammatory bowel disease, peptic ulcer disease, obesity combined with insulin-requiring diabetes, liver disease, or chronic renal disease within the past 6 months. - Positive for HBsAg or hepatitis C antibody within the past 2 weeks. - Chest radiograph within the past 60 days that shows cavity disease, infiltrates, or scars from prior disease that would preclude diagnosis of a new infectious process or drug-induced pneumonitis. AS PER AMENDMENT 1/10/97: - History of intolerance to zidovudine or lamivudine. Prior Medication: Excluded: - Prior chemotherapy for malignancy. Prior Treatment: Excluded: - Prior radiotherapy for malignancy. Alcohol abuse.
Total Enrollment: 30
Location and Contact Information:
Overall Study Official:
EgorinM, Study Chair,
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
United States
New England Med Ctr
Boston, Massachusetts, 02111
United States
Harper Hosp
Detroit, Michigan, 48201
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Community Research Initiative on AIDS
New York City, New York, 10001
United States
Additional Information:
Study ID Numbers: DATRI 013;
Study Start Date:
Record last reviewed: June 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000834
Other Hiv Infections Studies:
1. A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children with Prior Treatment
2. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose
3. A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
4. A Study of Azidothymidine in HIV-Infected Children
5. Effects of home visits on medication adherence in children and youth with HIV
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A Phase I Study of Methotrexate for HIV Infection
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