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
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
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/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Adefovir
Adefovir dipivoxil
Criteria
Inclusion Criteria

Patients 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.