Population pharmacokinetics and pharmacodynamics of efavirenz, nelfinavir, and indinavir: Adult AIDS Clinical Trial Group Study 398.
Marc Pfister, Line Labbé, Scott M Hammer...
https://pubmed.ncbi.nlm.nih.gov/12499180Completed
Phase 2
Age: 13Years +
All Genders
ID00000912
A Phase II, Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens (Placebo-Controlled) in Combination With Abacavir, Efavirenz, and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Protease Inhibitors and Loss of Virologic Suppression as Reflected by a Plasma HIV-1 RNA Concentration >= 1,000 Copies/ml
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
475
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copies/ml or less while on the treatment. This study evaluates the safety of these drug combinations, which include an experimental protease inhibitor (PI), amprenavir. Despite the success that many patients have had with PI treatment regimens, there is still a possibility that patients receiving PIs may continue to have high HIV blood levels. Because of this possibility, alternative drug combinations containing PIs are being studied. It appears that amprenavir, when taken with 3 or 4 other anti-HIV drugs, may be effective in patients with prior PI treatment experience.
CONDITIONS
Official Title
A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Have current virologic failure (2 consecutive HIV blood levels above 1,000 copies/ml) while on PIs.
- Are over 13 years of age (consent of parent or guardian required if under 18).
- Agree to practice abstinence or use effective methods of birth control during the study and for 90 days after.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have hepatitis within 90 days prior to study entry.
- Have a history of a peripheral neuropathy within 60 days of study entry.
- Have an unexplained temperature for a 7-day period.
- Have chronic diarrhea within 30 days prior to study entry.
- Have cancer requiring chemotherapy.
- Received any therapy for infection or other illness within 30 days prior to study entry.
- Have received certain other medications.
- Are pregnant or breast-feeding.
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: 45 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
USC Univ Hosp & Ambulatory Hlth Care Ctr / USC Med Ctr
Los Angeles, California, United States, 900334508
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
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
6
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
7
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
8
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
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
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States, 303652225
Status Unknown
16
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
17
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
18
Tripler Army Med Ctr
Tripler AMC, Hawaii, United States, 96859
Status Unknown
19
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
20
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
21
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
22
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Status Unknown
23
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Status Unknown
24
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
25
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
26
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Status Unknown
27
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
28
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
29
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
30
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
31
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
32
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
33
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
34
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
35
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
36
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
37
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
Status Unknown
38
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
39
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
40
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
Status Unknown
41
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
42
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States, 15213
Status Unknown
43
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
44
Univ of Washington
Seattle, Washington, United States, 981224304
Status Unknown
45
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
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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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Published Research Related To This Trial
Effect of coadministration of nelfinavir, indinavir, and saquinavir on the pharmacokinetics of amprenavir.
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Scott M Hammer, Florin Vaida, Kara K Bennett...
https://pubmed.ncbi.nlm.nih.gov/12095381Discrete stochastic models for compliance analysis based on an AIDS Clinical Trial Group (ACTG) study.
Junfeng Sun, H N Nagaraj, Nancy R Reynolds
https://pubmed.ncbi.nlm.nih.gov/17726714Joint modeling of longitudinal data and informative dropout time in the presence of multiple changepoints.
Pulak Ghosh, Kaushik Ghosh, Ram C Tiwari
https://pubmed.ncbi.nlm.nih.gov/21337357