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
|ClinicalTrials.gov Identifier: NCT00000914|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Indinavir sulfate Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Efavirenz||Not Applicable|
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:
- Ritonavir (RTV) plus soft gelatin capsule saquinavir (SQV-SGC) plus efavirenz (EFV).
- 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:
- Nelfinavir (NFV) plus EFV.
- RTV plus SQV-SGC plus EFV.
Patients failing NFV in Option 2 are randomized to one of two groups:
- Indinavir (IDV) plus EFV.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||800 participants|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of the Virologic Efficacy of Different Antiretroviral (AR) Treatment Strategies in HIV-Infected Individuals With Detectable Plasma HIV RNA Measurements After at Least 16 Weeks on Their Initial Protease Inhibitor-Containing AR Regimens|
|Actual Study Completion Date :||June 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000914
|United States, California|
|Community Consortium / UCSF|
|San Francisco, California, United States, 94110|
|United States, Colorado|
|Denver CPCRA / Denver Public Hlth|
|Denver, Colorado, United States, 802044507|
|United States, District of Columbia|
|Washington Reg AIDS Prog / Dept of Infect Dis|
|Washington, District of Columbia, United States, 20422|
|United States, Georgia|
|AIDS Research Consortium of Atlanta|
|Atlanta, Georgia, United States, 303081962|
|United States, Illinois|
|AIDS Research Alliance - Chicago|
|Chicago, Illinois, United States, 60657|
|United States, Louisiana|
|Louisiana Comm AIDS Rsch Prog / Tulane Univ Med|
|New Orleans, Louisiana, United States, 70112|
|United States, Michigan|
|Wayne State Univ - WSU/DMC / Univ Hlth Ctr|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hosp|
|Detroit, Michigan, United States, 48202|
|United States, New Jersey|
|Southern New Jersey AIDS Cln Trials / Dept of Med|
|Camden, New Jersey, United States, 08103|
|North Jersey Community Research Initiative|
|Newark, New Jersey, United States, 071032842|
|United States, New Mexico|
|Partners in Research / New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|United States, New York|
|Harlem AIDS Treatment Grp / Harlem Hosp Ctr|
|New York, New York, United States, 10037|
|United States, Oregon|
|The Research and Education Group|
|Portland, Oregon, United States, 97210|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Virginia|
|Richmond AIDS Consortium / Div of Infect Diseases|
|Richmond, Virginia, United States, 232980049|
|Study Chair:||Jay R. Kostman|
|Study Chair:||Lawrence R. Crane|