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| Sponsor: | Hoechst Marion Roussel |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002151 |
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 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
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
Show 24 Study Locations
More Information
| Study ID Numbers: | 221C, 028574PR0004, NDPR0004 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002151 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Drug Therapy, Combination 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 |