Overview
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Gilead SciencesTreatments:
Adefovir
Adefovir dipivoxil
Criteria
Inclusion CriteriaPatients must have:
- HIV infection with HIV RNA titer >= 2500 copies/ml (2.5 KEq/ml) plasma.
- CD4 count >= 200 cells/mm3.
- No new AIDS-defining event within the past 2 months.
- Life expectancy at least 1 year.
- Consent of parent or guardian if less than 18 years old.
- Tolerated antiretroviral therapy for the past 2 months.
NOTE:
- Kaposi's sarcoma is permitted provided patient has not received systemic therapy
within the past month.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Active, serious infections other than HIV that require parenteral antibiotic or
antiviral therapy.
- Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would
preclude oral medication.
- Malignancy other than Kaposi's sarcoma or basal cell carcinoma.
Concurrent Medication:
Excluded:
- Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
- Isoniazid.
- Rifampin.
- Investigational agents (unless approved by sponsor).
- Systemic chemotherapeutic agents.
Prior Medication:
Excluded:
- Parenteral antibiotic or antiviral therapy for another active, serious infection
within the past 2 weeks.
- Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within
the past month.
- Systemic therapy for KS within the past month.
Required:
- Antiretroviral regimen other than study drug.
Required:
- Antiretroviral therapy for at least the past 2 months. Current alcohol or substance
abuse that would interfere with compliance.