|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002150 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients |
| Official Title ICMJE | A Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients |
| 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. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Double-Blind, Safety Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Celgosivir hydrochloride |
| Study Arms / Comparison Groups | |
| Publications * | |
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 200 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002150 |
| Responsible Party | |
| Study ID Numbers ICMJE | 221B, 028574PR0003, NDPR0003 |
| Study Sponsor ICMJE | Hoechst Marion Roussel |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | March 1996 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|