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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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: | Endpoint Classification: Efficacy Study Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | June 2000 |
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.
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:
- 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.
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 | |
| 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 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
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000914 History of Changes |
| Other Study ID Numbers: | CPCRA 057, 11610 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Drug Therapy, Combination HIV Protease Inhibitors Ritonavir Indinavir |
Saquinavir Reverse Transcriptase Inhibitors Viral Load Nelfinavir |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protease Inhibitors Indinavir Ritonavir |
Nelfinavir HIV Protease Inhibitors Efavirenz Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 13, 2013