Completed

Safety and Antiviral Effects of Human Anti-CMV Monoclonal Antibody in AIDS Patients with CMV Viremia/Viruria

What is being tested

Sevirumab

Drug

Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

See protocol details

Summary

Principal SponsorSandoz

Last updated: June 24, 2005

Sourced from a government-validated database.Claim as a partner

This study focuses on a human anti-cytomegalovirus (CMV) monoclonal antibody, SDZ MSL-109, and its potential to treat patients with Acquired Immunodeficiency Syndrome (AIDS) or AIDS-related complex (ARC) who also have CMV viremia and/or viruria. The main goal is to evaluate the safety and tolerance of this antibody at various dosage levels. The study is important as it aims to find a new treatment option for these patients, potentially improving their care and addressing the challenges posed by CMV infections in AIDS and ARC patients.

NCT00002268

Principal SponsorSandoz

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 DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCytomegalovirus InfectionsHIV InfectionsAIDS-Related Opportunistic Infections

Criteria

6 inclusion criteria required to participate

A copy of the signed and witnessed consent form must be maintained with the investigator's study files

AIDS or be HIV positive with CD4 lymphocyte counts below 200 cells/mm3 and be receiving prophylaxis for Pneumocystis carinii pneumonia (PCP) (with or without prophylaxis for another opportunistic infection), but have no prior medical history of an opportunistic infection

Expected survival of = or > 6 months

Positive culture results documenting the presence of cytomegalovirus (CMV) viremia and/or viruria

Show More Criteria

17 exclusion criteria prevent from participating

Any active severe opportunistic infection

Any other experimental antiviral therapy

Any other experimental antiviral therapy within 2 weeks of study entry

Any other severe concomitant clinical condition

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 2 locations

Univ of Alabama at Birmingham

Birmingham, United StatesOpen Univ of Alabama at Birmingham in Google Maps

Univ TX Galveston Med Branch

Galveston, United States

Completed2 Study Centers