Completed

Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Adefovir dipivoxil

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.

NCT00002128
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Concurrent Medication: Allowed: AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry). Patients must have: Documented HIV infection or diagnosis of AIDS. Life expectancy of at least 3 months. Prior Medication: Allowed: Prior AZT, ddI, or ddC. Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy. Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. Gastrointestinal malabsorption syndrome or inability to receive oral medication. Concurrent Medication: Excluded: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Non-steroidal anti-inflammatory drugs. Aspirin. Prior Medication: Excluded within 2 weeks prior to study entry: Diuretics. Amphotericin B. Aminoglycoside antibiotics. Parenteral antibiotics. Other nephrotoxic agents. Other investigational agents. Excluded within 3 days prior to study entry: Non-steroidal anti-inflammatory drugs. Aspirin. Active substance abuse (including alcohol or drug abuse).

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Johns Hopkins Univ

Baltimore, United StatesOpen Johns Hopkins Univ in Google Maps
CompletedOne Study Center