|
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 NCT00002097 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. |
| Official Title ICMJE | A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. |
| Brief Summary | To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin. |
| Detailed Description | Cohorts of three patients each are treated at escalating doses of intravenous nystatin, administered every other day, until the MTD is reached. Each cohort is observed for toxicity for at least 2 weeks before escalation in subsequent patient cohorts is initiated. |
| Study Phase | Phase I |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Dose Comparison, Pharmacokinetics Study |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Drug: Nystatin |
| 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 | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Required:
Allowed:
Concurrent Treatment: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Prior Medication: Excluded within 2 weeks prior to study entry:
Prior Treatment: Excluded within 2 weeks prior to study entry:
|
| 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 | NCT00002097 |
| Responsible Party | |
| Study ID Numbers ICMJE | 103B, AR-91-35,606-004 |
| Study Sponsor ICMJE | Argus Pharmaceuticals |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | April 1994 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|