Clinical trial NCT00000735: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Virus Replication
T-Lymphocytes
Infusions, Intravenous
Immunologic Surveillance
Acquired Immunodeficiency Syndrome
ampligen
AIDS-Related Complex
Antiviral Agents
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed description: 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.

Patients entered in the study are given ampligen by intravenous infusion at hemophilia treatment centers once during the first week of the trial and twice a week during the following 12 weeks. The dose each patient receives is determined by the responses of earlier patients. If the status of the HIV infection does not improve after the first 13 weeks, ampligen will be stopped. Each patient maintains a daily diary listing any symptoms or problems that occur such as headache, nausea, or change in appetite. Other anti-HIV drugs cannot be taken during the trial, and aspirin or acetaminophen should not be taken for more than 72 hours at any time during the trial without consulting the research staff. Blood will be drawn at intervals during the 13-week trial and 8-week follow-up and used to determine the effect of ampligen on HIV and the immune system as well as to monitor toxicity and side effects.

Eligibility criteria: Inclusion Criteria

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.

Exclusion Criteria

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:
* Ribavirin.

Active drug or alcohol abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Hershey
country: United States
facility: Milton S Hershey Med Ctr
state: Pennsylvania
Study officials:
name: Eyster ME
role: STUDY_CHAIR
References:
citation: 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.