Completed

Assessment of Antiviral Effects and Safety of Butyldeoxynojirimycin (SC-48334) and AZT in HIV-1 Positive Patients

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

Butyldeoxynojirimycin

+ Zidovudine

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorG D Searle
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

This study focuses on HIV-1 infected individuals who have 200 to 500 CD4+ cells per cubic millimeter of blood. The main goal is to evaluate the antiviral effects of two drugs: Butyldeoxynojirimycin (SC-48334) and Zidovudine (AZT). The study aims to understand how these medications work when used together or separately. It's important because it could help improve treatment strategies for HIV-1 patients, potentially enhancing their quality of life and managing the virus more effectively. During the study, participants receive different doses of SC-48334 and AZT, either individually or in combination. The safety of increasing doses of SC-48334 when used with AZT is also assessed. Additionally, the study examines how the body processes these drugs when taken separately and together. This helps researchers understand the potential benefits and risks associated with these treatments.

NCT00002079
Principal SponsorG D Searle
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

3 inclusion criteria required to participate
Prior therapy with 12 - 48 weeks of AZT.
Documented HIV infection.
CD4 cell count 200 - 500 cells/mm3.
17 exclusion criteria prevent from participating
Cancer chemotherapy.
Any investigational drug other than SC-48334.
Whole-body irradiation within 6 months prior to study entry.
History of lactose intolerance.
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 9 locations

Dr Marcus Conant

San Francisco, United StatesOpen Dr Marcus Conant in Google Maps

Shared Med Research Foundation

Tarzana, United States

Stratogen of South Florida

Miami Beach, United States

Saint Joseph's Hosp / Infectious Disease Rsch Institute

Tampa, United States
Completed9 Study Centers