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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Glycovir
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alabama Therapeutics CRS
  • USC CRS
  • Stanford CRS
  • Ucsf Aids Crs
  • University of Colorado Hospital CRS
  • Univ. of Miami AIDS CRS
  • Northwestern University CRS
  • Rush Univ. Med. Ctr. ACTG CRS
  • Weiss Memorial Hosp.
  • Cook County Hosp. CORE Ctr.
  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
  • Methodist Hosp. of Indiana
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Washington U CRS
  • SUNY - Buffalo, Erie County Medical Ctr.
  • Beth Israel Med. Ctr. (Mt. Sinai)
  • Univ. of Rochester ACTG CRS
  • Unc Aids Crs
  • Wake County Health and Human Services CRS
  • Univ. of Cincinnati CRS
  • Hosp. of the Univ. of Pennsylvania CRS
  • University of Washington AIDS CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
G D Searle, Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000791
Brief Title
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
Official Title
A Phase II Double-Blind Study of Two Doses of SC-49483 in Combination With Zidovudine (ZDV) Versus ZDV
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
G D Searle, Glaxo Wellcome

4. Oversight

5. Study Description

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.
Detailed 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 4 weeks, at which time patients may receive open-label drug on an optional basis for 90 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Glycovir
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fischl MA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saag M
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama Therapeutics CRS
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
USC CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Ucsf Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
Univ. of Miami AIDS CRS
City
Miami
State/Province
Florida
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush Univ. Med. Ctr. ACTG CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Weiss Memorial Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Cook County Hosp. CORE Ctr.
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Methodist Hosp. of Indiana
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
SUNY - Buffalo, Erie County Medical Ctr.
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States
Facility Name
Beth Israel Med. Ctr. (Mt. Sinai)
City
New York
State/Province
New York
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
Unc Aids Crs
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Wake County Health and Human Services CRS
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Univ. of Cincinnati CRS
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Hosp. of the Univ. of Pennsylvania CRS
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background

Learn more about this trial

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

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