|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Argus Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002313 |
Purpose
To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Nystatin Drug: Didanosine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Safety Study |
| Official Title: | Extended Maintenance Protocol for Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection (NOTE: Continuation Study Intended Only for Patients Who Have Completed FDA 103B) |
Patients who have completed protocol FDA 103B are offered the option of receiving extended maintenance. Patients who have received no prior ddI are treated either with intravenous nystatin alone (at the same dose level administered in FDA 103B) or with a regimen of intravenous nystatin and ddI alternating on 3-week cycles. Treatment continues for 12 weeks.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Active drug or alcohol abuse.
Contacts and Locations More Information
| Study ID Numbers: | 103C, AR-91-35,606-005A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002313 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Nystatin Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome AIDS-Related Complex |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome AIDS-Related Complex Nystatin Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors |
Virus Diseases Anti-Bacterial Agents Didanosine Anti-Retroviral Agents HIV Infections Antifungal Agents Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Nystatin Infection Reverse Transcriptase Inhibitors Membrane Transport Modulators Anti-Bacterial Agents Anti-Retroviral Agents Antifungal Agents Therapeutic Uses Ionophores |
Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
