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A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celgosivir hydrochloride
Sponsored by
Hoechst Marion Roussel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, MDL 28574

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Prior antiretroviral agents for up to 6 months per agent. Patients must have: HIV infection. Asymptomatic or mildly symptomatic. CD4 count 301 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: Chemoprophylactic therapy for mycobacterial infection. Any nonstudy prescription medications without approval of investigator. Patients with the following prior conditions are excluded: History of grade 3 or 4 toxicity to <= 600 mg/day AZT. History of intolerance to lactose. Chronic diarrhea within 6 months prior to study entry. Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry. Prior Medication: Excluded: Antiretroviral therapy within 2 weeks prior to study entry. Prior HIV vaccines. Biological response modifiers within 30 days prior to study entry. Prior foscarnet. Any investigational drug with a washout < 5 half-lives prior to study entry. Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry. Recent history of alcohol and/or drug abuse.

Sites / Locations

  • Clinical Investigations Health Services
  • California Clinical Trials Med Group
  • Southwest Community Based AIDS Treatment Group - COMBAT
  • UCSF - San Francisco Gen Hosp
  • George Washington Univ / Hershey Med Ctr
  • Community Research Initiative of South Florida
  • Independent Investigator
  • North Broward Hosp District
  • Clinical Research Ctr
  • Independent Investigator
  • Ctr for Special Immunology
  • Univ of Kansas School of Medicine
  • New Orleans Institute of Clinical Investigation
  • Univ Health Ctr
  • Antibiotic Research Associates
  • North Jersey Community Research Initiative
  • Community Health Network
  • SUNY / Health Sciences Ctr at Stony Brook
  • Infectious Disease Associates
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
  • Guthrie Clinic
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Univ TX Galveston Med Branch
  • Houston Clinical Research Network

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Hoechst Marion Roussel
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1. Study Identification

Unique Protocol Identification Number
NCT00002151
Brief Title
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
Official Title
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hoechst Marion Roussel

4. Oversight

5. Study Description

Brief Summary
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

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, AIDS-Related Complex, Zidovudine, MDL 28574

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celgosivir hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Prior antiretroviral agents for up to 6 months per agent. Patients must have: HIV infection. Asymptomatic or mildly symptomatic. CD4 count 301 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: Chemoprophylactic therapy for mycobacterial infection. Any nonstudy prescription medications without approval of investigator. Patients with the following prior conditions are excluded: History of grade 3 or 4 toxicity to <= 600 mg/day AZT. History of intolerance to lactose. Chronic diarrhea within 6 months prior to study entry. Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry. Prior Medication: Excluded: Antiretroviral therapy within 2 weeks prior to study entry. Prior HIV vaccines. Biological response modifiers within 30 days prior to study entry. Prior foscarnet. Any investigational drug with a washout < 5 half-lives prior to study entry. Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry. Recent history of alcohol and/or drug abuse.
Facility Information:
Facility Name
Clinical Investigations Health Services
City
Mobile
State/Province
Alabama
ZIP/Postal Code
366880002
Country
United States
Facility Name
California Clinical Trials Med Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Southwest Community Based AIDS Treatment Group - COMBAT
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
George Washington Univ / Hershey Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Independent Investigator
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Clinical Research Ctr
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Independent Investigator
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Ctr for Special Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Univ of Kansas School of Medicine
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
New Orleans Institute of Clinical Investigation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ Health Ctr
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Antibiotic Research Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
North Jersey Community Research Initiative
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032842
Country
United States
Facility Name
Community Health Network
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
SUNY / Health Sciences Ctr at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Infectious Disease Associates
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Portland Veterans Adm Med Ctr / Rsch & Education Grp
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Guthrie Clinic
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359103
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550835
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States

12. IPD Sharing Statement

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A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

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