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| Sponsor: | Hoechst Marion Roussel |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002150 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Celgosivir hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind, Safety Study |
| Official Title: | A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following condition are excluded:
Unable or unwilling to comply with study procedures.
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Recent history of alcohol and/or drug abuse.
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Clinical Investigations Health Services | |
| Mobile, Alabama, United States, 366880002 | |
| United States, California | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| California Clinical Trials Med Group | |
| Beverly Hills, California, United States, 90211 | |
| Southwest Community Based AIDS Treatment Group - COMBAT | |
| Los Angeles, California, United States, 90027 | |
| United States, District of Columbia | |
| George Washington Univ / Hershey Med Ctr | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Community Research Initiative of South Florida | |
| Coral Gables, Florida, United States, 33146 | |
| North Broward Hosp District | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Independent Investigator | |
| Fort Lauderdale, Florida, United States, 33316 | |
| Clinical Research Ctr | |
| Sarasota, Florida, United States, 34239 | |
| Independent Investigator | |
| Vero Beach, Florida, United States, 32960 | |
| United States, Illinois | |
| Ctr for Special Immunology | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| United States, Kansas | |
| Univ of Kansas School of Medicine | |
| Wichita, Kansas, United States, 67214 | |
| United States, Michigan | |
| Univ Health Ctr | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Antibiotic Research Associates | |
| Kansas City, Missouri, United States, 64132 | |
| United States, New Jersey | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| United States, New York | |
| Community Health Network | |
| Rochester, New York, United States, 14620 | |
| SUNY / Health Sciences Ctr at Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, Ohio | |
| Infectious Disease Associates | |
| Toledo, Ohio, United States, 43608 | |
| United States, Pennsylvania | |
| Guthrie Clinic | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, Texas | |
| Houston Clinical Research Network | |
| Houston, Texas, United States, 77006 | |
| Univ TX Galveston Med Branch | |
| Galveston, Texas, United States, 775550835 | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 752359103 | |
More Information
| Study ID Numbers: | 221B, 028574PR0003, NDPR0003 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002150 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine MDL 28574 |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |