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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002151
• Other study ID #: 221C
• Secondary ID: 028574PR0004NDPR
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Celgosivir hydrochloride

Locations

Country	Name	City	State
United States	California Clinical Trials Med Group	Beverly Hills	California
United States	Ctr for Special Immunology	Chicago	Illinois
United States	Community Research Initiative of South Florida	Coral Gables	Florida
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Univ Health Ctr	Detroit	Michigan
United States	Independent Investigator	Fort Lauderdale	Florida
United States	North Broward Hosp District	Fort Lauderdale	Florida
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Houston Clinical Research Network	Houston	Texas
United States	Antibiotic Research Associates	Kansas City	Missouri
United States	Southwest Community Based AIDS Treatment Group - COMBAT	Los Angeles	California
United States	Clinical Investigations Health Services	Mobile	Alabama
United States	New Orleans Institute of Clinical Investigation	New Orleans	Louisiana
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Portland Veterans Adm Med Ctr / Rsch & Education Grp	Portland	Oregon
United States	Community Health Network	Rochester	New York
United States	UCSF - San Francisco Gen Hosp	San Francisco	California
United States	Clinical Research Ctr	Sarasota	Florida
United States	Guthrie Clinic	Sayre	Pennsylvania
United States	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York
United States	Infectious Disease Associates	Toledo	Ohio
United States	Independent Investigator	Vero Beach	Florida
United States	George Washington Univ / Hershey Med Ctr	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Hoechst Marion Roussel

Country where clinical trial is conducted

United States,