Completed

Ampligen and Zidovudine Combination for HIV-Related Immune Dysfunction

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ampligen

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorHEM Research
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study aims to assess the effectiveness of a drug called Ampligen in combination with another drug, Zidovudine (AZT), in treating individuals with HIV-related immune dysfunction. This condition is characterized by a specific count of T4 cells, which are a type of white blood cell, ranging from 100 to 300 cells per millimeter cubed. The study's goal is to determine if Ampligen can enhance the treatment when used together with AZT, potentially improving care for those living with this condition.

NCT00002269
Principal SponsorHEM Research
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

5 inclusion criteria required to participate
Absolute number of T4 cells 100-300 cells/mm3
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
Given informed consent
HIV-1 seropositivity
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8 exclusion criteria prevent from participating
Active drug abuse
Aspirin
Chemotherapy for Kaposi's sarcoma (KS)
Evidence of AIDS
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Miami Veterans Administration Med Ctr

Miami, United StatesOpen Miami Veterans Administration Med Ctr in Google Maps

Oregon Health Sciences Univ

Portland, United States

MCP Hahnemann Univ Hosp

Philadelphia, United States

Nelson Tebedo Community Clinic

Dallas, United States
Completed5 Study Centers