A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002115
- Run by
- Gilead Sciences
- People needed
- 20
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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.
Where it is running
- Univ of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.