Completed

Low Dose Oral Interferon Alfa-n3 for HIV+ Treatment

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What is being tested

Interferon alfa-n3

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

This study focuses on HIV+ individuals who experience symptoms. It's testing a new treatment approach using a low dose of an immunomodulator called Alferon LDO, which is a form of Interferon Alfa-n3. The goal is to see if this oral medication can help manage HIV symptoms. This research is important because it could potentially offer a new treatment option for HIV+ patients, improving their quality of life and addressing unmet needs in HIV care.

NCT00002018
Principal SponsorInterferon Sciences
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.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate
At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol

If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry

Seropositivity to HIV-1 by ELISA and Western blot

Written informed consent

22 exclusion criteria prevent from participating
Active intravenous (IV) drug abuse

Asymptomatic at study entry

BCG vaccine within 45 days of study entry

Chemotherapy within 45 days of study entry

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 1 location

Mount Sinai Med Ctr

New York, United StatesOpen Mount Sinai Med Ctr in Google Maps
CompletedOne Study Center