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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000914

Collaborator

(none)

800

Enrollment

Locations

53.3

Patients Per Site

Study Details

Study Description

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	N/A

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:

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 Design

Study Type:

Interventional

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 :

Jun 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium / UCSF	San Francisco	California	United States	94110
2	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	802044507
3	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia	United States	20422
4	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	303081962
5	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
6	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
7	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan	United States	48201
8	Henry Ford Hosp	Detroit	Michigan	United States	48202
9	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey	United States	08103
10	North Jersey Community Research Initiative	Newark	New Jersey	United States	071032842
11	Partners in Research / New Mexico	Albuquerque	New Mexico	United States	87131
12	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York	United States	10037
13	The Research and Education Group	Portland	Oregon	United States	97210
14	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
15	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia	United States	232980049