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

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Gilead Sciences

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Adefovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00002115
217A
GS-92-202

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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