Search / Trial NCT00000834

A Phase I Study of Methotrexate for HIV Infection

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Apply for Trial

Trial Information

Current as of June 14, 2024

Completed

Keywords

Methotrexate Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine Lamivudine Disease Progression Anti Inflammatory Agents Anti Hiv Agents

Description

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-...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000834_2024-06-14.pdf

4.5 MB

NCT00000834_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Washington, District Of Columbia, United States

Wichita, Kansas, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

Dallas, Texas, United States

Detroit, Michigan, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Discussion 0