CompletedPhase 1

A Phase I Study of Methotrexate for HIV Infection

United States30 participants

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 b…

Trial details

NCT IDNCT00000834

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL