Completed

Safety, Tolerance, Pharmacokinetics, and Anti-HIV Activity of Adefovir Dipivoxil in HIV-Infected Patients

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What is being tested

Adefovir dipivoxil

Drug
Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

From 18 to 60 Years
+14 Eligibility Criteria
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

This a double-blind, placebo-controlled, randomized Phase I/II study of the safety, tolerance, pharmacokinetics, and anti-HIV activity of adefovir dipivoxil in HIV-infected patients naive to antiretroviral therapy. Patients are randomized to receive a single daily dose of adefovir dipivoxil or matching placebo tablet for 4 weeks.

NCT00002206
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

45 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 DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections

Criteria

4 inclusion criteria required to participate
A minimum life expectancy of 12 months
HIV infection, as indicated by a history of seropositivity for HIV-1 infection (ELISA confirmed with Western blot)
Peripheral blood CD4 cell count greater than or equal to 150 cells/mm3 on at least 1 measurement within 28 days prior to enrollment
Plasma HIV-1 RNA greater than or equal to 5,000 copies/ml within 28 days of study entry
10 exclusion criteria prevent from participating
A malignancy other than cutaneous Kaposi's sarcoma (KS). (NOTE: Patients with biopsy-confirmed KS are eligible, but must not have received any systemic therapy (including chemotherapy) for KS within 4 weeks prior to study entry
Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy. Patients should be considered recovered from such infectious episodes when at least 2 weeks have elapsed following the cessation of parenteral antibiotic therapy
Aminoglycoside antibiotics, amphotericin B, cidofovir, diuretics, foscarnet, ganciclovir, itraconazole, fluconazole, ketoconazole (topical allowed), isoniazid, rifampin, rifabutin, clarithromycin, azithromycin, chemotherapeutic agents (systemic), systemic corticosteroids, other agents with significant nephrotoxic potential, other agents that inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and other investigational agents
Antiretroviral therapy, including nucleoside analogues, nonnucleoside reverse transcriptase inhibitors, protease inhibitors, or investigational antiretroviral agents (antiretroviral therapy may be started after completion of the Day 35 follow-up visit)
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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 5 locations

Anderson Clinical Research

Washington D.C., United StatesOpen Anderson Clinical Research in Google Maps

Johns Hopkins Univ Clinical Pharmacology

Baltimore, United States

Anderson Clinical Research

New York, United States

Anderson Clinical Research

Philadelphia, United States
Completed5 Study Centers