Clinical trial NCT00002161: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Adenine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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