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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Adefovir dipivoxil (Drug)

Phase: N/A

Status: Completed

Sponsored by: Gilead Sciences

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.

Clinical Details

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

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Hopital Edouard Herriot, Lyon Cedex 03, France

Hopital Sainte-Marguerite, Marseille, France

Klinikum Der Johann Wolfgang Goethe Universitat, Frankfurt, Germany

Universitatskrankenhaus Eppendorf, Hamburg, Germany

Klinikum der Ludwig-Maximilians-Universitaet, Muenchen, Germany

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 Kingdom

St Paul's Hosp, Vancouver, British Columbia, Canada

Pacific Oaks Research, Beverly Hills, California 90211, United States

ViRx Inc, Palm Springs, California 92262, United States

Ctr for AIDS Research / Education and Service (CARES), Sacramento, California 95814, United States

Kaiser Foundation Hospital, San Francisco, California 94118, United States

San Francisco Gen Hosp / UCSF AIDS Program, San Francisco, California 94110, United States

San Francisco VA Med Ctr, San Francisco, California 94121, United States

Blick Med Associates, Stamford, Connecticut 06901, United States

Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Community AIDS Resource Inc, Coral Gables, Florida 33146, United States

TheraFirst Med Ctrs Inc, Fort Lauderdale, Florida 33308, United States

Duval County Health Department, Jacksonville, Florida 32206, United States

Health Positive, Safety Harbor, Florida 34695, United States

Center for Quality Care, Tampa, Florida 33609, United States

Georgia Research Associates, Atlanta, Georgia 30342, United States

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States

Indiana Univ Infectious Disease Research Clinic, Indianapolis, Indiana 46202, United States

Johns Hopkins Univ School of Medicine, Baltimore, Maryland 21205, United States

Albany Med College, Albany, New York 12208, United States

Bentley-Salick Med Practice, New York, New York 10011, United States

James Jones MD, New York, New York 10019, United States

Mount Sinai Med Ctr, New York, New York 10029, United States

St Luke Roosevelt Hosp, New York, New York 10011, United States

Wake Forest Univ School of Medicine, Winston Salem, North Carolina 27157, United States

Associates of Med and Mental Health, Tulsa, Oklahoma 74114, United States

Sunnybrook Health Science Centre, Toronto, Ontario, Canada

The Research and Education Group, Portland, Oregon 97210, United States

Centre hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada

Miriam Hosp, Providence, Rhode Island 02906, United States

Roger Williams Med Ctr, Providence, Rhode Island 02908, United States

Vanderbilt Univ School of Medicine, Nashville, Tennessee 37212, United States

Univ of Texas Southwestern Med Ctr of Dallas, Dallas, Texas 75235, United States

Univ of Texas Med Branch, Galveston, Texas 77555, United States

Thomas Street Clinic, Houston, Texas 77009, United States

Univ of Utah Med School / Clinical Trials Ctr, Salt Lake City, Utah 84108, United States

Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States

N Touch Research Corp, Seattle, Washington 98122, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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