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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000914 |
Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Nelfinavir mesylate Drug: Efavirenz |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Efficacy Study |
| 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 |
| Estimated Enrollment: | 800 |
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:
Option 2 consists of treatment with a single PI versus double PI. Patients who choose Option 2 are randomized to 1 of 2 groups:
Patients failing NFV in Option 2 are randomized to one of two groups:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if you:
Contacts and Locations| 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 | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| Southern New Jersey AIDS Cln Trials / Dept of Med | |
| Camden, New Jersey, United States, 08103 | |
| 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 FIGHT | |
| 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 |
More Information
| Study ID Numbers: | CPCRA 057 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 30, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000914 History of Changes |
| Health Authority: | United States: Federal Government |
|
Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Indinavir |
Saquinavir Reverse Transcriptase Inhibitors Viral Load Nelfinavir |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Nelfinavir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz RNA Virus Infections |
HIV Protease Inhibitors Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |
