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| Descriptive Information Fields | |
| Brief 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 |
| 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 |
| Brief Summary | 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. |
| Detailed Description | Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose. |
| Study Phase | Phase I |
| Study Type † | Interventional |
| Study Design † | Treatment, Dose Comparison, Pharmacokinetics Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | HIV Infections |
| Intervention † | Drug: Adefovir dipivoxil |
| MEDLINE PMIDs | 8585716 |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 15 |
| Start Date † | |
| Completion Date | |
| Eligibility Criteria † | 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:
|
| Gender | Both |
| Ages | 18 Years to 60 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | United States |
| Administrative Information Fields | |
| NCT ID † | NCT00002128 |
| Organization ID | 232A |
| Secondary IDs †† | GS-93-401 |
| Study Sponsor † | Gilead Sciences |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | July 1994 |
| First Received Date † | November 2, 1999 |
| Last Updated Date | June 23, 2005 |