A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
2 other identifiers
interventional
210
1 country
22
Brief Summary
To determine the safety and anti-HIV activity of two doses of SC-49483 in combination with zidovudine (AZT) versus AZT alone. To determine the influences of viral phenotype on the anti-HIV activity of these treatment regimens. SC-49483 has no inherent activity against HIV-1 but is converted in the intestinal wall to SC-48334, which has demonstrated anti-HIV activity. Since SC-49483 causes significantly less gastrointestinal toxicity than SC-48334, the combination of SC-49483 with AZT may improve the benefits of both drugs in patients with HIV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 1, 1995
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Required:
- PCP prophylaxis (trimethoprim/sulfamethoxazole, dapsone, or aerosolized pentamidine) in patients with CD4 count \<= 200 cells/mm3.
- Allowed:
- Topical antifungal agents, ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections, as medically indicated.
- Maintenance therapy for Mycobacteria disease with isoniazid, ethambutol, rifampin, pyrazinamide, clofazimine, ciprofloxacin, clarithromycin, or rifabutin.
- Maintenance therapy for toxoplasmosis with pyrimethamine, sulfadiazine, or clindamycin.
- Maintenance therapy for herpes simplex virus with acyclovir at \<= 1000 mg/day.
- Recombinant erythropoietin and G-CSF, if indicated.
- Antibiotics for bacterial infections.
- Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics.
- Concurrent Treatment:
- Allowed:
- Localized radiation therapy and limited intralesional therapy for cutaneous Kaposi's sarcoma.
- Patients must have:
- +7 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following condition are excluded:
- Malignancy other than minimal Kaposi's sarcoma.
- Concurrent Medication:
- Excluded:
- Antiretroviral therapies (other than study drug).
- Biologic response modifiers.
- Systemic corticosteroids for \> 21 consecutive days.
- Foscarnet.
- Systemic cytotoxic chemotherapy for a malignancy.
- Patients with the following prior conditions are excluded:
- History of cataracts.
- History of intolerance to AZT at \<= 600 mg/day.
- Unexplained temperature \>= 38.5 degrees C that persists for any 7 days within the 30 days prior to study entry.
- Chronic diarrhea (defined as \>= 3 stools per day) that persists for any 15 days within the 30 days prior to study entry.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- G D Searlecollaborator
- Glaxo Wellcomecollaborator
Study Sites (22)
Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, 90033, United States
Stanford CRS
Palo Alto, California, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Miami AIDS CRS
Miami, Florida, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Weiss Memorial Hosp.
Chicago, Illinois, 60640, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14260, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27514, United States
Wake County Health and Human Services CRS
Raleigh, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
Philadelphia, Pennsylvania, United States
University of Washington AIDS CRS
Seattle, Washington, 98104, United States
Related Publications (1)
Johnson VA, Bassett RL, Stanley KE, Saag MS, Fischl MA. Predictors of syncytium-inducing viral phenotype in a phase II double-blind trial of SC-49483 plus ZDV vs. ZDV. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:102 (abstract no 205)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fischl MA
- STUDY CHAIR
Saag M
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
July 1, 1995
Last Updated
October 28, 2021
Record last verified: 2021-10