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NCT00002269 Clinical Trial

A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

HIV Infections Clinical Trial

Official title:
A Multicenter, Double-Blind, Controlled Study to Evaluate Ampligen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002269
Other study ID # 073A
Secondary ID AMP-700
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date August 1991
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To evaluate ampligen at two dosage levels given twice weekly in combination with zidovudine (AZT) versus AZT alone in individuals with HIV-related immune dysfunction defined as T4 count between 100 and 300 cells/mm3.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria

Patients must have:

- HIV-1 seropositivity.

- Absolute number of T4 cells 100-300 cells/mm3.

- Given informed consent.

- Zidovudine (AZT) therapy for 6 months prior to study entry.

- At least one of the listed HIV-related clinical symptoms or opportunistic infections:

- weight loss > 10 percent, unexplained diarrhea, unexplained intermittent fever, oral candidiasis > 1 month, decreased Karnofsky, oral hairy leukoplakia, chronic fatigue.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Evidence of AIDS.

- Intercurrent acute medical disorder.

Concurrent Medication:

Excluded:

- Chemotherapy for Kaposi's sarcoma (KS).

- Aspirin.

- Non-steroidal anti-inflammatory drugs.

Patients with the following are excluded:

- Inability to return for treatment and evaluation for 12 months.

- Intercurrent acute medical disorder.

- Evidence of AIDS.

- Receiving chemotherapy for Kaposi's sarcoma (KS).

- Unwilling or unable to give informed consent.

Required:

- Zidovudine (AZT).

Required at least 6 months prior to study entry:

- Zidovudine (AZT).

Active drug abuse.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ampligen

• Zidovudine

Locations
Country Name City State
United States Nelson Tebedo Community Clinic Dallas Texas
United States Dr Patricia Salvato Houston Texas
United States Miami Veterans Administration Med Ctr Miami Florida
United States MCP Hahnemann Univ Hosp Philadelphia Pennsylvania
United States Oregon Health Sciences Univ Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
HEM Research

Country where clinical trial is conducted

United States, 

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