A Phase I Study of Methotrexate for HIV Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000834
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 30
- Expected to finish
- 2002-06-01
- Last updated by the study team
- 2021-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
Where it is running
- Cedars Sinai Med Ctr — Los Angeles, California, United States
- Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- Univ of Kansas School of Medicine — Wichita, Kansas, United States
- New England Med Ctr — Boston, Massachusetts, United States
- Harper Hosp — Detroit, Michigan, United States
- Community Research Initiative on AIDS — New York, New York, United States
- Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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