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A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks Clinical research trials and A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks. A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks clinical trial. Subjects frequently obtain the most expert healthcare possible for their A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks  A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks
A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to compare different treatments for HIV infection to see which works best to lower HIV levels and to raise the number of CD4 cells (cells of the immune system that fight infection), in HIV-positive individuals who have been on a protease inhibitor-containing drug regimen for at least 16 weeks. Researchers have found that combination anti-HIV therapy (multiple drugs given together) can help prevent AIDS-related illnesses and help people with AIDS live longer. In this study, the anti-HIV drug efavirenz (EFV) will be tested with 1 or 2 other protease inhibitors (PIs) to see which combination works best to treat HIV infection. EFV has been shown to limit the amount of HIV virus produced by infected cells.
Details: Current recommendations for the initial treatment of HIV infection have centered on the reduction of plasma HIV levels. It has been shown that a combination of 2 nucleoside reverse transcriptase inhibitors (NRTIs) and a PI is the most effective barriers to disease progression. This study attempts to demonstrate these data. Two options are available for patients whose initial PI-containing regimen has failed to suppress viral replication. Option 1 consists of immediate versus deferred use of a nonnucleoside reverse transcriptase inhibitor (NNRTI). Patients who choose Option 1 are randomized to 1 of 2 groups: 1. Ritonavir (RTV) plus soft gelatin capsule saquinavir (SQV-SGC) plus efavirenz (EFV). 2. RTV plus SQV-SGC. Option 2 consists of treatment with a single PI versus double PI. Patients who choose Option 2 are randomized to 1 of 2 groups: 1. Nelfinavir (NFV) plus EFV. 2. RTV plus SQV-SGC plus EFV. Patients failing NFV in Option 2 are randomized to one of two groups: 1. Indinavir (IDV) plus EFV. 2. RTV plus SQV-SGC plus EFV. Patients remain on study treatment regimens for 8 weeks. Follow-up visits, including history and physical evaluations, take place at specified intervals during the next 12 months.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are HIV-positive. - Have an HIV RNA count of at least 400 copies/ml. - Are at least 13 years old (need consent if under 18). - Have been on antiretroviral treatment (including at least 2 NRTIs) for at least 16 weeks prior to study entry. - Agree to practice abstinence or to use effective methods of birth control, including a barrier method, during the study. Exclusion Criteria You will not be eligible for this study if you: - Are pregnant or breast-feeding. - Have active opportunistic (HIV-associated) infections. - Have taken nelfinavir (NFV) for more than 2 weeks after failing indinavir/ritonavir (IDV/RTV) treatment or have taken IDV/RTV for more than 2 weeks after failing NFV treatment. - Have used any protease inhibitor other than NFV or IDV/RTV for more than 2 weeks. - Have used any non-nucleoside reverse transcriptase inhibitor (NNRTI) for more than 1 week.
Total Enrollment: 800
Location and Contact Information:
Overall Study Official:
JayKostman, Study Chair,
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
United States
The Research and Education Group
Portland, Oregon, 97210
United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
United States
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
United States
Henry Ford Hosp
Detroit, Michigan, 48202
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 232980049
United States
Community Consortium / UCSF
San Francisco, California, 94110
United States
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York City, New York, 10037
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
United States
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 802044507
United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 303081962
United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
United States
Additional Information:
Study ID Numbers: CPCRA 057;
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000914
Other Hiv Infections Studies:
1. Comparison of Two Dosing Regimens of GW433908/Ritonavir Versus Lopinavir/Ritonavir for 48 Weeks in HIV Patients Who Have Taken Protease Inhibitors and Experienced Virological Failure
2. Evaluation of the Safety of and Immune Response to an HIV Vaccine in Healthy Adults
3. Pulmonary Complications of HIV Infection Study (PACS)
4. Salvage Treatment, Resistance Testing, and Withdrawal of Anti-HIV Drugs for HIV Patients Failing Current Anti-HIV Treatment
5. A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma
Related Studies:
Other HIV Infections Clinical Trials
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A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks
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