Search / Trial NCT00000791

A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine

Description

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...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000791_2024-07-23.pdf

4.5 MB

NCT00000791_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Palo Alto, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Chicago, Illinois, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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