Know Cancer

or
forgot password

A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment in HIV-Infected Patients


Phase 1
18 Years
60 Years
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment in HIV-Infected Patients


Patients receive AZT daily and intravenous PMEA three times weekly for 4 weeks. An MTD will
be defined for this regimen.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Prophylactic therapy with aerosolized pentamidine, oral trimethoprim/sulfamethoxazole
(Bactrim, Septra) or dapsone, and fluconazole or ketoconazole IF on a stable regimen
for at least 4 weeks prior to study entry.

Patients must have:

- HIV seropositivity.

- Mean CD4 count <= 500 cells/mm3.

- Been receiving AZT at 500 mg daily for at least 4 weeks prior to study entry.

- Life expectancy of at least 3 months.

NOTE:

- Kaposi's sarcoma is permitted provided patient has not received any systemic therapy
for KS within the past 4 weeks. Patients with a history of another malignancy must be
disease free for 6 months or more prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Inadequate venous access.

- Active, serious infections (other than HIV infection) requiring parenteral antibiotic
therapy.

- Clinically significant cardiac disease, including symptoms of ischemia, congestive
heart failure, or clinically significant arrhythmia.

- Active malignancy other than Kaposi's sarcoma.

- Mental incapacity or illness that may affect compliance.

Concurrent Medication:

Excluded:

- ddI or ddC.

- Interferon alpha.

- Ganciclovir.

- Foscarnet.

- Diuretics.

- Investigational agents including d4T.

- Chemotherapeutic agents.

- Amphotericin B.

- Aminoglycoside antibiotics.

- Other nephrotoxic agents.

- Immunomodulatory agents.

- Parenteral therapy for an active, serious infection (other than HIV infection).

Prior Medication:

Excluded within 2 weeks prior to study entry:

- ddI or ddC.

- Interferon alpha.

- Ganciclovir.

- Foscarnet.

- Diuretics.

- Investigational agents including d4T.

- Chemotherapeutic agents.

- Amphotericin B.

- Aminoglycoside antibiotics.

- Other nephrotoxic agents.

- Immunomodulatory agents.

Excluded within 4 weeks prior to study entry:

Systemic therapy for Kaposi's sarcoma.

Required:

- AZT at a stable dose for at least 4 weeks prior to study entry. Current use of
illicit drugs (e.g., heroin or cocaine). Ingestion of substantial alcohol.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

217B

NCT ID:

NCT00002326

Start Date:

Completion Date:

Related Keywords:

  • HIV Infections
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • Zidovudine
  • Adenine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Natl Cancer InstituteBethesda, Maryland  20892