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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00002161

Collaborator

(none)

400

Enrollment

Locations

14.8

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Adefovir dipivoxil	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	East Bay AIDS Ctr	Berkeley	California	United States	94705
3	Kraus Med Partners	Los Angeles	California	United States	90509
4	San Francisco Gen Hosp	San Francisco	California	United States	94115
5	Santa Clara Valley Med Ctr	San Jose	California	United States	951282699
6	San Mateo County Med Ctr / San Mateo County AIDS Prog	San Mateo	California	United States	94403
7	Pacific Oaks Research	Sherman Oaks	California	United States	91403
8	Harbor UCLA Med Ctr	Torrance	California	United States	90502
9	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
10	Institute for Clinical Research	Washington	District of Columbia	United States	20422
11	Univ of South Florida	St. Petersburg	Florida	United States	33705
12	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	303081962
13	Chicago Ctr for Clinical Research	Chicago	Illinois	United States	60610
14	Northwestern Univ Med Ctr	Chicago	Illinois	United States	60611
15	Tulane Univ / Tulane / LSU Clinical Trials Unit	New Orleans	Louisiana	United States	70122
16	Harvard Univ / Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
17	Wayne State Univ / Univ Health Ctr	Detroit	Michigan	United States	48201
18	Albany Med College / Clinical Pharmacy Studies	Albany	New York	United States	12208
19	Saint Vincent's Med Ctr	New York	New York	United States	10011
20	Carolinas Med Ctr	Charlotte	North Carolina	United States	28204
21	The Research and Education Group	Portland	Oregon	United States	97210
22	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37212
23	Dallas VA Med Ctr	Dallas	Texas	United States	75216
24	Univ of Texas	Galveston	Texas	United States	77555
25	Houston Clinical Research Network	Houston	Texas	United States	77004
26	Univ of Utah School of Medicine	Salt Lake City	Utah	United States	84132
27	Univ of Wisconsin	Madison	Wisconsin	United States	53792