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A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV Clinical research trials and A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV clinical trial. Participants typically obtain the most effective healthcare available for their A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV  A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , G D Searle,Glaxo Wellcome
Synopsis: 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.
Details: 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. 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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: - 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 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. 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.
Total Enrollment: 210
Location and Contact Information:
Overall Study Official:
FischlMA, Study Chair,
Beth Israel Med Ctr
New York City, New York, 10003
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Wake County Dept of Health
Raleigh, North Carolina, 27610
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
North Central Bronx Hosp / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, 94609
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Rose Med Ctr
Denver, Colorado, 80262
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942041
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Samaritan Village Inc / Bronx Municipal Hosp
Bronx, New York, 10461
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Columbia Presbyterian Med Ctr
New York City, New York, 100323784
United States
Yale Univ / New Haven
New Haven, Connecticut, 065102483
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Montefiore Adolescent AIDS Prog / Bronx Municipal Hosp
Bronx, New York, 10461
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Additional Information:
Study ID Numbers: ACTG 259;
Study Start Date:
Record last reviewed: July 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000791
Other Hiv Infections Studies:
1. Intensive Pharmacokinetics of the Nelfinavir Rifabutin Interaction in Patients with HIV-Related Tuberculosis Treated with a Rifabutin-Based Regimen
2. An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Dideoxycytidine (ddC) in Patients With AIDS or Advanced ARC Who Previously Demonstrated Intolerance to Zidovudine (AZT) in Protocol N3300 or N3492
3. A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
4. Phase III Open Label Atazanavir (BMS-232632) in Combination with Ritonavir or Saquinavir, and Lopinavir/Ritonavir, each with Tenofovir and a Nucleoside in Subjects with HIV
5. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
Related Studies:
Other HIV Infections Clinical Trials
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A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
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