Completed
Safety, Tolerance, and Pharmacokinetics of Adefovir in Advanced HIV Disease
Study Aim
This phase 1 study aims to evaluate the safety, tolerance, and how your body processes Adefovir in individuals with advanced HIV disease.
What is being tested
Adefovir
Drug
Who is being recruted
Blood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
From 18 to 60 Years
+25 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Summary
Principal SponsorGilead Sciences
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
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
20 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 SyndromeHIV Infections
Criteria
8 inclusion criteria required to participate
Elevated p24 antigen ( > 40 pg/ml)
HIV seropositivity
Life expectancy of at least 3 months
Mean CD4 count <= 100 cells/mm3
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17 exclusion criteria prevent from participating
Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy
Acyclovir at doses >= 2 g/day
Aminoglycoside antibiotics
Amphotericin B
Show More Criteria
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
CompletedOne Study Center