A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
NCT ID: NCT00000791
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
210 participants
INTERVENTIONAL
1995-07-31
Brief Summary
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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.
Detailed Description
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Patients are randomized to receive AZT alone or in combination with one of two doses of SC-49483, administered three times daily. Treatment continues for 16 to 24 weeks. Per 07/19/94 amendment: At the end of 24 weeks, blinded treatment continues for an additional 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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Glycovir
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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:
* Documented HIV infection.
* Per 07/19/94 amendment, one of the following:
* CD4 count 150 - 350 cells/mm3 within 60 days prior to study entry AND prior AZT for no more than 12 months cumulative (given with or without ddI or ddC).
* CD4 count 50 - 350 cells/mm3 within 60 days prior to study entry AND no prior antiretroviral therapy.
* MT-2 cell assay within 60 days prior to study entry.
NOTE:
* Minimal Kaposi's sarcoma is permitted.
Exclusion Criteria
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.
Prior Medication:
Excluded:
* More than 6 months (more than 12 months per 07/19/94 amendment) cumulative prior therapy with AZT.
* Prior induction or maintenance therapy with foscarnet.
* Any investigational drug within 30 days prior to study entry.
* Prior SC-49483 or SC-48334.
* Prior ddC, ddI, or stavudine (d4T) as monotherapy.
* Interferon or interleukin within 30 days prior to study entry.
* Prior non-nucleoside reverse transcriptase inhibitors (e.g., NVP, ATV).
* Systemic corticosteroids for \> 21 consecutive days.
* Acute treatment for a serious infection or any opportunistic infection within 14 days prior to study entry.
* Prior combination therapy with AZT, ddI, and/or ddC within 30 days prior to study entry.
13 Years
ALL
No
Sponsors
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G D Searle
INDUSTRY
Glaxo Wellcome
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Fischl MA
Role: STUDY_CHAIR
Saag M
Role: STUDY_CHAIR
Locations
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Alabama Therapeutics CRS
Birmingham, Alabama, United States
USC CRS
Los Angeles, California, United States
Stanford CRS
Palo Alto, California, United States
Ucsf Aids Crs
San Francisco, California, 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, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, United States
Weiss Memorial Hosp.
Chicago, Illinois, 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, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 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, 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, United States
Countries
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References
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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)
Other Identifiers
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11236
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 259
Identifier Type: -
Identifier Source: org_study_id