Completed

PEG IL-2 and Antiviral Therapy for HIV Positive Individuals

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to treat HIV positive individuals by evaluating the combined effect of PEG IL-2 and antiviral therapy.

What is being tested

Interleukin-2, Polyethylene Glycolated

+ Zidovudine

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

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

Four escalating doses of PEG IL-2 are studied. Patients are stratified by CD4 level. CD4 levels in Group A are 200 to 500 cells/mm3; in Group B - 1 to less than 200 cells/mm3. Further stratification is by p24 positive or negative, antiviral therapy for more or less than a year, and zidovudine (AZT) versus didanosine (ddI). The duration of PEG IL-2 treatment is a maximum of 28 weeks. This is an outpatient study; patients will be observed for four hours after the first dose of PEG IL-2 and for one hour after subsequent doses.

NCT00001997
Principal SponsorChiron Corporation
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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

2 inclusion criteria required to participate
HIV seropositivity by commercially available ELISA

Meet Disease Status criteria

14 exclusion criteria prevent from participating
Active opportunistic infection requiring hospitalization or exclude medication

Active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements

Any of the symptoms or conditions listed in Exclusion - Co-Existing Conditions

Any prior therapy with interleukin-2 (IL-2) or PEG IL-2

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

Dr David R Senechek

San Francisco, United StatesOpen Dr David R Senechek in Google Maps
CompletedOne Study Center