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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000914
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 27, 2012
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Masking: None (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
Actual Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000914

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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 FIGHT
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States, 232980049
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Jay R. Kostman
Study Chair: Lawrence R. Crane

Mannheimer S, Friedland G, Matts J, Child C, Chesney M. Antiretroviral adherence correlates with quality of life. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 485)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000914    
Other Study ID Numbers: CPCRA 057
11610 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: March 27, 2012
Last Verified: March 2012
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Viral Load
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers