A Clinical Trial To Evaluate the Toxicity and Antiviral Effects of a Range of Doses of Ampligen in p24 Antigen Positive HIV-Infected Patients With AIDS or ARC

NCT00000735 | Completed Phase 1

• 2 other identifiers: ACTG 05411028
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

To determine the safety of intravenous infusion of ampligen in symptomatic HIV-infected patients at several dose levels, to determine the maximum dose that can be tolerated, and to measure the effects of ampligen on the HIV virus infection, immune function, and clinical condition. Ampligen is a suitable drug for clinical trials against HIV because it has been shown to stimulate the immune system and to inhibit replication of HIV in vitro at doses that can be achieved without noticeable harmful side effects.

Conditions

HIV Infections

Keywords

Virus Replication; T-Lymphocytes; Infusions, Intravenous; Immunologic Surveillance; Acquired Immunodeficiency Syndrome; ampligen; AIDS-Related Complex; Antiviral Agents

Interventions

Ampligen DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemophiliacs are included. Patients must have:
• Consistently positive serum HIV p24 antigen (= or \> 70 pg/ml) defined by the Abbott HIV antigen test. This demonstration must be seen on two occasions, each separated by at least 72 hours, the last of which must be within 2 weeks of starting therapy.
• Positive HIV antibody test.
• Prior Medication:
• Allowed:
• Acyclovir for short course (7 days).
• Ketoconazole for short course (7 days).
• Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
• Trimethoprim / sulfamethoxazole for PCP prophylaxis.

You may not qualify if:

• Co-existing Condition:
• Patients with AIDS encephalopathy as a sole indicator are excluded.
• Patients with AIDS encephalopathy as a sole indicator are excluded.
• Prior Medication:
• Excluded:
• Other experimental medication.
• Antineoplastic therapy.
• Amphotericin B.
• Ganciclovir.
• Excluded within 14 days of study entry:
• Biologic modifiers.
• Corticosteroids.
• Excluded within 30 days of study entry:
• Other antiretroviral agents.
• Excluded within 60 days of study entry:

Sponsors & Collaborators

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

Study Sites (2)

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Milton S Hershey Med Ctr

Hershey, Pennsylvania, 170330850, United States

Location

Related Publications (1)

• Armstrong JA, McMahon D, Huang XL, Pazin GJ, Gupta P, Rinaldo CR Jr, Schoenfeld DA, Gaccione P, Tripoli CA, Bensasi S, et al. A phase I study of ampligen in human immunodeficiency virus-infected subjects. J Infect Dis. 1992 Oct;166(4):717-22. doi: 10.1093/infdis/166.4.717.

  PMID: 1527407 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

poly(I).poly(c12,U)

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

Study Officials

• Eyster ME

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (2)