Clinical trial NCT00002426: A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Adefovir Dipivoxil as Intensification Therapy in Combination With Highly Active Antiretroviral Therapy (HAART) in HIV Infected Patients With HIV-1 RNA > 50 and <= 400 Copies/Ml
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
RNA, Viral
VX 478
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 390
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs (HAART) to patients who have a viral load (level of HIV in the blood) between 50 and 400 copies/ml.

Detailed description: Patients are randomized to 1 of 2 arms in a 2:1 ratio. Approximately 260 patients receive ADV and approximately 130 patients receive placebo. Patients receive ADV or placebo in addition to L-carnitine and their current stable HAART regimen. Each patient receives blinded study medication for 48 weeks and is evaluated at Weeks 16, 24, and 48. Patients who reach the primary endpoint of virologic failure prior to Week 48 may continue blinded study medication or receive open-label ADV at the investigator's discretion. In both cases, patients continue their study visits as per the original visit schedule. Virologic failure is defined as 2 consecutive HIV-1 RNA measurements, after baseline, above 400 copies/ml (measured by the Roche Amplicor HIV-1 Monitor UltraSensitive assay) drawn at least 14 days apart. All patients who complete study visits without treatment-limiting ADV toxicity may continue open-label ADV in the Maintenance Phase at the discretion of the principal investigator.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have been on a stable HAART regimen consisting of at least 3 antiretroviral drugs for at least 16 weeks prior to study entry.
* Have a CD4 count of 50 cells/mm3 or more.
* Have a viral load greater than 50 and less than or equal to 400 copies/ml within 14 days prior to study entry.
* Have had at least 1 additional viral load in the past that was less than or equal to 400 copies/ml while on your current stable HAART regimen.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: Sacramento
country: United States
facility: Ctr for AIDS Research / Education and Service (CARES)
state: California
city: San Francisco
country: United States
facility: San Francisco Gen Hosp / UCSF AIDS Program
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: San Francisco
country: United States
facility: San Francisco VA Med Ctr
state: California
city: Stamford
country: United States
facility: Blick Med Associates
state: Connecticut
city: Washington
country: United States
facility: Georgetown Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Coral Gables
country: United States
facility: Community AIDS Resource Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: TheraFirst Med Ctrs Inc
state: Florida
city: Jacksonville
country: United States
facility: Duval County Health Department
state: Florida
city: Safety Harbor
country: United States
facility: Health Positive
state: Florida
city: Tampa
country: United States
facility: Center for Quality Care
state: Florida
city: Atlanta
country: United States
facility: Georgia Research Associates
state: Georgia
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Infectious Disease Research Clinic
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Univ School of Medicine
state: Maryland
city: Albany
country: United States
facility: Albany Med College
state: New York
city: New York
country: United States
facility: Bentley-Salick Med Practice
state: New York
city: New York
country: United States
facility: St Luke Roosevelt Hosp
state: New York
city: New York
country: United States
facility: James Jones MD
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Winston Salem
country: United States
facility: Wake Forest Univ School of Medicine
state: North Carolina
city: Tulsa
country: United States
facility: Associates of Med and Mental Health
state: Oklahoma
city: Portland
country: United States
facility: The Research and Education Group
state: Oregon
city: Providence
country: United States
facility: Miriam Hosp
state: Rhode Island
city: Providence
country: United States
facility: Roger Williams Med Ctr
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt Univ School of Medicine
state: Tennessee
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: Thomas Street Clinic
state: Texas
city: Salt Lake City
country: United States
facility: Univ of Utah Med School / Clinical Trials Ctr
state: Utah
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: Seattle
country: United States
facility: N Touch Research Corp
state: Washington
city: Vancouver
country: Canada
facility: St Paul's Hosp
state: British Columbia
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: Hopital Sainte-Marguerite
city: Frankfurt
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe Universitat
city: Hamburg
country: Germany
facility: Universitatskrankenhaus Eppendorf
city: Muenchen
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet
city: London
country: United Kingdom
facility: Chelsea and Westminster Hosp
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free Hosp
city: London
country: United Kingdom
facility: Senior Lecturer in GU Medicine
Study officials:
References: