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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002161
• Other study ID #: 232C
• Secondary ID: GS-96-408
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: May 1997
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Adefovir dipivoxil

Locations

Country	Name	City	State
United States	Albany Med College / Clinical Pharmacy Studies	Albany	New York
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	East Bay AIDS Ctr	Berkeley	California
United States	Univ of Alabama at Birmingham	Birmingham	Alabama
United States	Harvard Univ / Massachusetts Gen Hosp	Boston	Massachusetts
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	Chicago Ctr for Clinical Research	Chicago	Illinois
United States	Northwestern Univ Med Ctr	Chicago	Illinois
United States	Dallas VA Med Ctr	Dallas	Texas
United States	Wayne State Univ / Univ Health Ctr	Detroit	Michigan
United States	Univ of Texas	Galveston	Texas
United States	Houston Clinical Research Network	Houston	Texas
United States	Kraus Med Partners	Los Angeles	California
United States	Univ of Wisconsin	Madison	Wisconsin
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Tulane Univ / Tulane / LSU Clinical Trials Unit	New Orleans	Louisiana
United States	Saint Vincent's Med Ctr	New York	New York
United States	The Research and Education Group	Portland	Oregon
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	San Francisco Gen Hosp	San Francisco	California
United States	Santa Clara Valley Med Ctr	San Jose	California
United States	San Mateo County Med Ctr / San Mateo County AIDS Prog	San Mateo	California
United States	Pacific Oaks Research	Sherman Oaks	California
United States	Univ of South Florida	St. Petersburg	Florida
United States	Harbor UCLA Med Ctr	Torrance	California
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Institute for Clinical Research	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States,