A Phase I Study of Methotrexate for HIV Infection

NCT00000834 | Completed Phase 1

• 2 other identifiers: DATRI 01311742
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

HIV Infections

Keywords

Methotrexate; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Lamivudine; Disease Progression; Anti-Inflammatory Agents; Anti-HIV Agents

Interventions

Lamivudine DRUG

Methotrexate DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[AS PER AMENDMENT 7/31/96: Prior mucocutaneous herpes infection requiring systemic treatment with an antiviral agent (e.g., acyclovir); history of topical antiviral therapy is permitted\].

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Cedars Sinai Med Ctr

Los Angeles, California, 90048, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Univ of Kansas School of Medicine

Wichita, Kansas, 67214, United States

Location

New England Med Ctr

Boston, Massachusetts, 02111, United States

Location

Harper Hosp

Detroit, Michigan, 48201, United States

Location

Community Research Initiative on AIDS

New York, New York, 10001, United States

Location

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Disease Progression

Interventions

Lamivudine; Methotrexate; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thymidine

Study Officials

• Egorin M

  STUDY CHAIR

• Fox L

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 2002
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (7)