NCT00002269

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

August 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency SyndromeampligenAIDS-Related ComplexZidovudine

Interventions

AmpligenDRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Miami Veterans Administration Med Ctr

Miami, Florida, 33125, United States

Location

Oregon Health Sciences Univ

Portland, Oregon, 97201, United States

Location

MCP Hahnemann Univ Hosp

Philadelphia, Pennsylvania, 19102, United States

Location

Nelson Tebedo Community Clinic

Dallas, Texas, 75219, United States

Location

Dr Patricia Salvato

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

poly(I).poly(c12,U)Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1991-08

Locations

US(5)