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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002128 |
Purpose
To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Adefovir dipivoxil |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients |
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 2 weeks prior to study entry:
Excluded within 3 days prior to study entry:
Contacts and Locations
More Information
| Study ID Numbers: | 232A, GS-93-401 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002128 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents Adenine |
|
Anti-Infective Agents RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Infection Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Adefovir dipivoxil Adefovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors |