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A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure Clinical research trials and A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure. A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

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A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure



A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure

For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
Details: To maximize the likelihood of a favorable response to salvage therapy, 4 or 5 drug regimens should be studied. Regimens containing fewer drugs, particularly those lacking a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as efavirenz, are likely to result in an unacceptable rate of virological failure. Therefore, this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors (NRTIs), the NNRTI efavirenz, and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir. Patients are randomly selected to receive 1 of the following 4 treatment regimens: Arm A: Ritonavir, saquinavir, efavirenz, and 2 new NRTIs. Arm B: Indinavir, efavirenz and 2 new NRTIs. Arm C: Amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 3/22/00: Patients have the option to increase the APV dose or to add low-dose ritonavir. APV will continue to be provided by the study; ritonavir will not be provided by the study.] Arm D: Indinavir, amprenavir, efavirenz, and 2 new NRTIs. [AS PER AMENDMENT 6/28/99: All treatment regimens must include at least 1 new NRTI.] [AS PER AMENDMENT 3/22/00: ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10, 2000, regardless of virologic response. Patients may also add antiretrovirals of their choice to this regimen (not provided by the study).] Clinical assessments are taken at Weeks 2, 4, 8, 12, 16, and every 8 weeks thereafter for the duration of the study. In addition, 2 substudies are being conducted: a drug-interaction substudy and a drug-exposure substudy. [AS PER AMENDMENT 3/22/00: Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued.]
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are over 13 years old (need consent of parent or guardian if under 18). - Are HIV-positive. - Currently have virologic failure (more than 1,000 copies of HIV RNA per ml). - Agree to abstinence or use of effective birth control during the study. - Have been taking NFV for the past 12 weeks. Exclusion Criteria Patients will not be eligible for this study if they: - Have a fever for 7 days or diarrhea for 30 days before study entry. - Have a history of peripheral neuropathy within 60 days of study entry. - Have hepatitis. - Have any malignancy (cancer) other than minimal Kaposi's sarcoma. - Are pregnant or breast-feeding. - Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry. - Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days. - Have received an HIV vaccine 30 days before study entry. - Are receiving certain other medications.
Total Enrollment: 300

Location and Contact Information:

Overall Study Official:
JohnWilliam Powderly,  Study Chair, 

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Cook County Hosp
Chicago,  Illinois,  60612
United States
 

Univ of Miami School of Medicine
Miami,  Florida,  331361013
United States
 

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose,  California,  951282699
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Willow Clinic
Menlo Park,  California,  94025
United States
 

UCLA CARE Ctr
Los Angeles,  California,  90095
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Univ of Washington
Seattle,  Washington,  98104
United States
 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Stanford Univ Med Ctr
Stanford,  California,  943055107
United States
 

Beth Israel Med Ctr
New York City,  New York,  10003
United States
 

Univ of North Carolina
Chapel Hill,  North Carolina,  275997215
United States
 

Univ of Puerto Rico
San Juan,  ,  009365067
Puerto Rico
 

Duke Univ Med Ctr
Durham,  North Carolina,  27710
United States
 

San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco,  California,  941102859
United States
 

Harvard (Massachusetts Gen Hosp)
Boston,  Massachusetts,  02114
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Marin County Specialty Clinic
San Rafael,  California,  94903
United States
 

St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis,  Missouri,  63112
United States
 

Chelsea Ctr
New York City,  New York,  10021
United States
 

San Mateo AIDS Program / Stanford Univ
Stanford,  California,  943055107
United States
 

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

Howard Univ
Washington D.C.,  District of Columbia,  20059
United States
 

Case Western Reserve Univ
Cleveland,  Ohio,  44106
United States
 

Univ of Pennsylvania at Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

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

Cornell Univ Med Ctr
New York City,  New York,  10021
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Emory Univ
Atlanta,  Georgia,  30308
United States
 

Beth Israel Deaconess - West Campus
Boston,  Massachusetts,  02215
United States
 

Julio Arroyo
West Columbia,  South Carolina,  29169
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 


Additional Information:
Study ID Numbers:
  ACTG 400;  Substudy A5013s.,Substudy A5022s.
Study Start Date: January 1998
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000918

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