Completed
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
800
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 15 locations
1
Community Consortium / UCSF
San Francisco, California, United States, 94110
Status Unknown
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
Status Unknown
3
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, United States, 20422
Status Unknown
4
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 303081962
Status Unknown
5
AIDS Research Alliance - Chicago
Chicago, Illinois, United States, 60657
Status Unknown
6
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States, 70112
Status Unknown
7
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, United States, 48201
Status Unknown
8
Henry Ford Hosp
Detroit, Michigan, United States, 48202
Status Unknown
9
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States, 08103
Status Unknown
10
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
Status Unknown
11
Partners in Research / New Mexico
Albuquerque, New Mexico, United States, 87131
Status Unknown
12
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
13
The Research and Education Group
Portland, Oregon, United States, 97210
Status Unknown
14
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Status Unknown
15
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, United States, 232980049
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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