A Phase I Study of Methotrexate for HIV Infection (NCT00000834) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000834
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)