Completed
Phase 3
Age: 18Years +
All Genders
ID00000841
A Randomized, Double-Blind, Phase III Study of Indinavir Sulfate With Open-Label Zidovudine (AZT) and Lamivudine (3TC) in Subjects With HIV Infection With CD4 Cell Counts <= 200 Cells/mm3 and >= 6 Months of Prior AZT Experience
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
1750
Participants Needed
87
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
CONDITIONS
Official Title
A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis.
Allowed:
- Topical or oral antifungal agents (other than oral ketoconazole).
- Approved agents for opportunistic infections.
- Antibiotics unless specifically excluded.
- Systemic corticosteroids for no more than 21 days.
- Vitamins.
- Recombinant erythropoietin.
- G-CSF.
- Regularly prescribed medications such as allergy medications, antidepressants, antipyretics, analgesics, oral contraceptives, megestrol, and testosterone.
Concurrent Treatment:
Allowed:
- Acupuncture.
- Visualization techniques.
Patients must have:
- HIV infection.
- CD4 count <= 200 cells/mm3.
- At least 6 months total prior AZT therapy.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Malignancy requiring systemic therapy other than minimal Kaposi's sarcoma.
Concurrent Medication:
Excluded:
- Antiretrovirals other than study drugs.
- Rifabutin and rifampin.
- Investigational drugs other than indinavir sulfate.
- Systemic cytotoxic chemotherapy.
- Oral ketoconazole.
- Chronic systemic corticosteroids.
- Herbal therapies.
Patients with the following prior conditions are excluded:
- Unexplained temperature > 38.5 C for any 7 days within 30 days prior to study entry.
- Chronic diarrhea persisting for 15 days within 30 days prior to study entry.
- History of acute or chronic pancreatitis.
- Acute hepatitis within 30 days prior to study entry.
- Grade 2 or worse bilateral peripheral neuropathy within 60 days prior to study entry.
- Dose-limiting intolerance to prior AZT at 600 mg/day.
Prior Medication:
Excluded:
- More than 1 week of prior 3TC.
- Any prior protease inhibitors.
- Rifampin or rifabutin within 14 days prior to study entry.
Excluded within 30 days prior to study entry:
- Erythropoietin.
- G-CSF or GM-CSF.
- Non-nucleoside reverse transcriptase inhibitors.
- Interferons.
- Interleukins.
- HIV vaccines.
- Any experimental therapy.
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: 87 locations
1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status Unknown
2
Children's Hosp of Los Angeles
Los Angeles, California, United States, 90027
Status Unknown
3
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
4
UCLA CARE Ctr
Los Angeles, California, United States, 90095
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
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
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
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
12
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, United States, 80262
Status Unknown
13
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, United States, 80262
Status Unknown
14
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
15
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, United States, 20037
Status Unknown
16
Georgetown Univ Hosp
Washington D.C., District of Columbia, United States, 20037
Status Unknown
17
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
18
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
19
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
20
Emory Univ
Atlanta, Georgia, United States, 30308
Status Unknown
21
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States, 303652225
Status Unknown
22
Queens Med Ctr
Honolulu, Hawaii, United States, 96816
Status Unknown
23
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
24
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
25
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
26
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Status Unknown
27
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
Status Unknown
28
Illinois Masonic Med Ctr
Chicago, Illinois, United States, 606575147
Status Unknown
29
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
30
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
31
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
32
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States, 52242
Status Unknown
33
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Status Unknown
34
Tulane Med Ctr Hosp
New Orleans, Louisiana, United States, 70112
Status Unknown
35
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
Status Unknown
36
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States, 212052196
Status Unknown
37
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
38
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
39
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Status Unknown
40
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
41
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, United States, 01605
Status Unknown
42
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
Status Unknown
43
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
44
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States, 55101
Status Unknown
45
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
46
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
Status Unknown
47
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
48
North Shore Univ Hosp
Great Neck, New York, United States, 11021
Status Unknown
49
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
50
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
51
Kaplan Cancer Ctr / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
52
Manhattan Veterans Administration / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
53
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Status Unknown
54
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
55
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
56
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
57
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, United States, 10029
Status Unknown
58
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Status Unknown
59
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
60
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
61
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
62
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Status Unknown
63
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States, 10467
Status Unknown
64
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States, 10468
Status Unknown
65
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
66
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28203
Status Unknown
67
Duke Univ Med Ctr
Durham, North Carolina, United States, 27710
Status Unknown
68
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
Status Unknown
69
Central Prison/Women's Prison in Raleigh / NC
Raleigh, North Carolina, United States, 276260540
Status Unknown
70
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
71
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
Status Unknown
72
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
73
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
74
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Status Unknown
75
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
Status Unknown
76
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
Status Unknown
77
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
78
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
79
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States, 37920
Status Unknown
80
Meharry Med College
Nashville, Tennessee, United States, 37203
Status Unknown
81
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 37203
Status Unknown
82
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
83
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, United States, 77030
Status Unknown
84
Univ of Washington
Seattle, Washington, United States, 981224304
Status Unknown
85
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, United States, 532130127
Status Unknown
86
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, Puerto Rico, 00956
Status Unknown
87
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
Conference updates show promising drug data.
https://pubmed.ncbi.nlm.nih.gov/113647693-drug therapy reduces deaths and new AIDS-related illnesses by 50%.
R Baker
https://pubmed.ncbi.nlm.nih.gov/11364527Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320.
L M Demeter, M D Hughes, R W Coombs...
https://pubmed.ncbi.nlm.nih.gov/11730396Detection of replication-competent human immunodeficiency virus type 1 (HIV-1) in cultures from patients with levels of HIV-1 RNA in plasma suppressed to less than 500 or 50 copies per milliliter.
Lisa M Demeter, Ronald J Bosch, Robert W Coombs...
https://pubmed.ncbi.nlm.nih.gov/12037070A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team.
S M Hammer, K E Squires, M D Hughes...
https://pubmed.ncbi.nlm.nih.gov/9287227Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine.
Paul M Coplan, John R Cook, George W Carides...
https://pubmed.ncbi.nlm.nih.gov/15307012Gender differences in health-related quality of life in patients with HIV/AIDS.
Joseph M Mrus, Paige L Williams, Joel Tsevat...
https://pubmed.ncbi.nlm.nih.gov/15892437Variations in self-rated health among patients with HIV infection.
Joseph M Mrus, Bruce R Schackman, Albert W Wu...
https://pubmed.ncbi.nlm.nih.gov/16547789Generalizing evidence from randomized clinical trials to target populations: The ACTG 320 trial.
Stephen R Cole, Elizabeth A Stuart
https://pubmed.ncbi.nlm.nih.gov/20547574