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NCT00002426 Clinical Trial

A Study on the Safety and Effectiveness of Adefovir Dipivoxil in Combination With Anti-HIV Therapy (HAART) in HIV-Positive Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002426
Other study ID # 232K
Secondary ID GS-97-415
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date December 1999
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

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 390
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Adefovir dipivoxil

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

Sponsors (1)
Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  United Kingdom, 

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