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

NCT ID: NCT00000914

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2000-06-30

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.

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.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; HIV Protease Inhibitors; Ritonavir; Indinavir; Saquinavir; Reverse Transcriptase Inhibitors; Viral Load; Nelfinavir

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Indinavir sulfate

Intervention Type: DRUG

Ritonavir

Intervention Type: DRUG

Nelfinavir mesylate

Intervention Type: DRUG

Efavirenz

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay R. Kostman

Role: STUDY_CHAIR

Lawrence R. Crane

Role: STUDY_CHAIR

Locations

Community Consortium / UCSF

San Francisco, California, United States

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, United States

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States

AIDS Research Alliance - Chicago

Chicago, Illinois, United States

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, United States

Henry Ford Hosp

Detroit, Michigan, United States

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, United States

North Jersey Community Research Initiative

Newark, New Jersey, United States

Partners in Research / New Mexico

Albuquerque, New Mexico, United States

Harlem AIDS Treatment Grp / Harlem Hosp Ctr

New York, New York, United States

The Research and Education Group

Portland, Oregon, United States

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States

Richmond AIDS Consortium / Div of Infect Diseases

Richmond, Virginia, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

11610

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPCRA 057

Identifier Type: -

Identifier Source: org_study_id