A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Sponsor

Hoechst Marion Roussel (Industry)

Overall Status

Completed

CT.gov ID

NCT00002150

Collaborator

(none)

200

Enrollment

Locations

8.7

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Celgosivir hydrochloride	Phase 2

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

HIV infection.
Asymptomatic or mildly symptomatic.
CD4 count 100 - 300 cells/mm3.

Prior Medication:

Allowed:

Prior antiretroviral agents for up to 6 months per agent.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Investigations Health Services	Mobile	Alabama	United States	366880002
2	California Clinical Trials Med Group	Beverly Hills	California	United States	90211
3	Southwest Community Based AIDS Treatment Group - COMBAT	Los Angeles	California	United States	90027
4	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
5	George Washington Univ / Hershey Med Ctr	Washington	District of Columbia	United States	20037
6	Community Research Initiative of South Florida	Coral Gables	Florida	United States	33146
7	Independent Investigator	Fort Lauderdale	Florida	United States	33316
8	North Broward Hosp District	Fort Lauderdale	Florida	United States	33316
9	Clinical Research Ctr	Sarasota	Florida	United States	34239
10	Independent Investigator	Vero Beach	Florida	United States	32960
11	Ctr for Special Immunology	Chicago	Illinois	United States	60657
12	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
13	Univ of Kansas School of Medicine	Wichita	Kansas	United States	67214
14	Univ Health Ctr	Detroit	Michigan	United States	48201
15	Antibiotic Research Associates	Kansas City	Missouri	United States	64132
16	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
17	Community Health Network	Rochester	New York	United States	14620
18	SUNY / Health Sciences Ctr at Stony Brook	Stony Brook	New York	United States	117948153
19	Infectious Disease Associates	Toledo	Ohio	United States	43608
20	Guthrie Clinic	Sayre	Pennsylvania	United States	18840
21	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	752359103
22	Univ TX Galveston Med Branch	Galveston	Texas	United States	775550835
23	Houston Clinical Research Network	Houston	Texas	United States	77006