Completed
A Phase II, Randomized, Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of >= 1,000 Copies/ml
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-05-21
300
Participants Needed
39
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
CONDITIONS
Official Title
A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this study if they:
- Are over 13 years old (need consent of parent or guardian if under 18).
- Are HIV-positive.
- Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).
- Agree to abstinence or use of effective birth control during the study.
- Have been taking NFV for the past 12 weeks.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have a fever for 7 days or diarrhea for 30 days before study entry.
- Have a history of peripheral neuropathy within 60 days of study entry.
- Have hepatitis.
- Have any malignancy (cancer) other than minimal Kaposi's sarcoma.
- Are pregnant or breast-feeding.
- Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.
- Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.
- Have received an HIV vaccine 30 days before study entry.
- Are receiving certain other medications.
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: 39 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
3
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
4
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
5
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
6
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
7
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
8
Marin County Specialty Clinic
San Rafael, California, United States, 94903
Status Unknown
9
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
10
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
11
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
12
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
13
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
14
Emory Univ
Atlanta, Georgia, United States, 30308
Status Unknown
15
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
16
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
17
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
18
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
19
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
20
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
21
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
22
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
23
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
24
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
25
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
26
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
27
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
28
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
29
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
30
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
31
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
32
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
33
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
34
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
35
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
36
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
37
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
38
Univ of Washington
Seattle, Washington, United States, 98104
Status Unknown
39
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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