A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002115

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Acquired Immunodeficiency Syndrome, Antiviral Agents, Adenine

Brief summary

To study the safety, tolerance, pharmacokinetics, and anti-HIV effects of PMEA ( adefovir ) when administered daily by intravenous (IV) and/or subcutaneous (SC) injection in patients with advanced HIV disease.

Detailed description

Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.

Interventions

DRUGAdefovir

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Concurrent Medication: Allowed: * Other antiretroviral therapy IF on a stable dose for at least 4 weeks prior to study entry. * Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable prophylactic regimen for at least 4 weeks prior to study entry. Patients must have: * HIV seropositivity. * Elevated p24 antigen (\> 40 pg/ml). * Mean CD4 count \<= 100 cells/mm3. * Life expectancy of at least 3 months. Prior Medication: Allowed: * Other prior antiretroviral therapy. * Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole (Bactrim, Septra) or dapsone, and fluconazole or ketoconazole.

Exclusion criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Inadequate venous access. * Active serious infection (other than HIV infection) requiring parenteral antibiotic therapy. * Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia. * Psychiatric disturbance or illness that may affect compliance. * Malignancy other than Kaposi's sarcoma. Concurrent Medication: Excluded: * Investigational agents other than stavudine (d4T). * Interferon-alpha. * Ganciclovir. * Foscarnet. * Diuretics. * Amphotericin B. * Aminoglycoside antibiotics. * Other nephrotoxic agents. * Acyclovir at doses \>= 2 g/day. Prior Medication: Excluded within 2 weeks prior to study entry: * Investigational agents other than stavudine (d4T). * Interferon-alpha. * Ganciclovir. * Foscarnet. * Diuretics. * Amphotericin B. * Aminoglycoside antibiotics. * Other nephrotoxic agents. Excluded within 4 weeks prior to study entry: * Systemic therapy for Kaposi's sarcoma. Substance abuse.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026