|
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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 Clinical research trials and 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 health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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. 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often get the best healthcare possible for their 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 condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > 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 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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): Gilead Sciences ,
Synopsis: To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 400
Location and Contact Information:
Univ of South Florida
St. Petersburg, Florida, 33705
United States
Univ of Wisconsin
Madison, Wisconsin, 53792
United States
Wayne State Univ / Univ Health Ctr
Detroit, Michigan, 48201
United States
Saint Vincent's Med Ctr
New York City, New York, 10011
United States
San Mateo County Med Ctr / San Mateo County AIDS Prog
San Mateo, California, 94403
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28204
United States
East Bay AIDS Ctr
Berkeley, California, 94705
United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
United States
Houston Clinical Research Network
Houston, Texas, 77004
United States
Tulane Univ / Tulane / LSU Clinical Trials Unit
New Orleans, Louisiana, 70122
United States
San Francisco Gen Hosp
San Francisco, California, 94115
United States
Harvard Univ / Massachusetts Gen Hosp
Boston, Massachusetts, 02114
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Dallas VA Med Ctr
Dallas, Texas, 75216
United States
Santa Clara Valley Med Ctr
San Jose, California, 951282699
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37212
United States
Institute for Clinical Research
Washington D.C., District of Columbia, 20422
United States
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
United States
Univ of Texas
Galveston, Texas, 77555
United States
Albany Med College / Clinical Pharmacy Studies
Albany, New York, 12208
United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Kraus Med Partners
Los Angeles, California, 90509
United States
Pacific Oaks Research
Sherman Oaks, California, 91403
United States
Saint Vincent's Med Ctr
New York City, New York, 10011
United States
Additional Information:
Study ID Numbers: 232C; GS-96-408
Study Start Date:
Record last reviewed: May 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002161
Other Hiv Infections Studies:
1. A Phase I Trial of Intranasal Peptide T: Safety, Toxicity, and Pharmacokinetics in Human Immunodeficiency Virus-1 (HIV-1) Infected Patients.
2. Safety, Tolerance, Efficacy and Pharmacokinetics of Multiple Doses of sCD4-PE40 in the Treatment of HIV-Infected Individuals
3. A Randomized, Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir and Emtricitabine vs. 400 mg Lopinavir /100 mg Ritonavir BID in Combination with Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
4. A Registry of Tuberculosis Cases in the CPCRA
5. A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
Related Studies:
Other HIV Infections Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
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
|
|
|
|
|
|
|
|