A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Gilead Sciences
Patients receive a single IV or SC dose of PMEA daily for 4 weeks. A maximum tolerated dose will be defined for these regimens.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
