Completed

Safety, Tolerance, and Efficacy of sCD4-PE40 in HIV-1 Treatment

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What is being tested

Alvircept sudotox

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorPharmacia and Upjohn
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-infected individuals and explores the safety and tolerance of a drug called sCD4-PE40, also known as alvircept sudotox. The goal is to understand how the body responds to increasing numbers of weekly infusions of this drug at a fixed dose. The research aims to address the current challenges in HIV treatment, potentially improving care for those affected by this condition. During the study, participants receive the sCD4-PE40 drug through infusions. The effects of the drug are then measured by examining various parameters. These include T lymphocyte subsets, plasma HIV RNA and cellular HIV proviral DNA in PBMC and CD4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels. These measurements help determine the drug's impact on the body and the progression of HIV.

NCT00002087
Principal SponsorPharmacia and Upjohn
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

2 inclusion criteria required to participate
CD4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry
HIV positivity confirmed by Western blot
8 exclusion criteria prevent from participating
Antiretroviral agents within 2 months prior to study entry
Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated Kaposi's sarcoma
Hemophilia or other clotting disorders
Known anti-HIV medication within 60 days prior to 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

Stanford Univ Med Ctr

Stanford, United StatesOpen Stanford Univ Med Ctr in Google Maps
CompletedOne Study Center