Completed
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
1292
Participants Needed
96
Research Sites
N/A
Total Duration
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
To determine the relative clinical efficacy of zidovudine ( AZT ) plus didanosine (ddI), AZT plus zalcitabine ( ddC ), AZT alternating monthly with ddI, and AZT/ddI plus nevirapine in HIV-infected patients with advanced disease. The rapid emergence of resistant HIV strains has been observed in patients receiving monotherapy with a nucleoside analog or non-nucleoside reverse transcriptase inhibitor. Use of combination therapy with two nucleoside drugs or convergent combination therapy with two nucleosides and a non-nucleoside RT inhibitor may minimize the evolution of these resistant HIV strains. Since toxicity is a major problem in patients with advanced disease who are receiving combination nucleoside therapy, alternating the two drugs may provide a way of retaining several benefits of combination therapy while minimizing the increased toxicity.
CONDITIONS
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
You may qualify if you...
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
Excluded within 7 days prior to study entry:
Prior Treatment:
Excluded:
Active alcohol or drug abuse.
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
Total: 96 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
Huntington Memorial Hosp / Children's Hosp of Los Angeles
Pasadena, California, United States, 91105
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
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
10
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
11
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
12
Olive View Med Ctr
Sylmar, California, United States, 91342
Status Unknown
13
Harbor UCLA Med Ctr
Torrance, California, United States, 90502
Status Unknown
14
Denver Dept of Health and Hosps
Denver, Colorado, United States, 80262
Status Unknown
15
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, United States, 80262
Status Unknown
16
Rose Med Ctr
Denver, Colorado, United States, 80262
Status Unknown
17
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
18
Yale Univ / New Haven
New Haven, Connecticut, United States, 065102483
Status Unknown
19
HIV Ctr - District of Columbia Gen Hosp
Washington D.C., District of Columbia, United States, 200072197
Status Unknown
20
Whitman - Walker Clinic / Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States, 200072197
Status Unknown
21
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States, 20007
Status Unknown
22
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, United States, 20037
Status Unknown
23
Howard Univ
Washington D.C., District of Columbia, United States, 20059
Status Unknown
24
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
25
Univ of South Florida
Tampa, Florida, United States, 33612
Status Unknown
26
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
27
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
28
Cook County Hosp
Chicago, Illinois, United States, 60612
Status Unknown
29
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
30
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States, 60640
Status Unknown
31
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
32
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States, 46202
Status Unknown
33
Univ of Louisville / East Tennesee Comprehensive Hem Ctr
Louisville, Kentucky, United States, 40202
Status Unknown
34
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Status Unknown
35
Boston Med Ctr
Boston, Massachusetts, United States, 02118
Status Unknown
36
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
37
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, United States, 01605
Status Unknown
38
Hennepin County Med Clinic
Minneapolis, Minnesota, United States, 55415
Status Unknown
39
Univ of Minnesota
Minneapolis, Minnesota, United States, 55455
Status Unknown
40
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States, 55101
Status Unknown
41
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
42
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States, 681985130
Status Unknown
43
Dartmouth - Hitchcock Med Ctr / Med Ctr Cntrl Massachusetts
Lebanon, New Hampshire, United States, 03756
Status Unknown
44
Robert Wood Johnson Med School / Hershey Med Ctr
New Brunswick, New Jersey, United States, 08903
Status Unknown
45
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
46
Adirondack Med Ctr at Saranac Lake
Albany, New York, United States, 122083479
Status Unknown
47
Albany Med College / Division of HIV Medicine A158
Albany, New York, United States, 122083479
Status Unknown
48
Mid - Hudson Care Ctr
Albany, New York, United States, 122083479
Status Unknown
49
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 112032098
Status Unknown
50
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
51
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, United States, 11373
Status Unknown
52
North Shore Univ Hosp
Manhasset, New York, United States, 11030
Status Unknown
53
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
54
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
55
Saint Clare's Hosp and Health Ctr
New York, New York, United States, 10019
Status Unknown
56
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
57
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Status Unknown
58
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, United States, 10029
Status Unknown
59
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
60
Columbia Presbyterian Med Ctr
New York, New York, United States, 100323784
Status Unknown
61
Harlem Hosp Ctr
New York, New York, United States, 10037
Status Unknown
62
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
Status Unknown
63
SUNY / State Univ of New York
Syracuse, New York, United States, 13210
Status Unknown
64
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States, 10461
Status Unknown
65
Comprehensive Health Care Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
66
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
67
Montefiore Family Health Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
68
Samaritan Village Inc / Bronx Municipal Hosp
The Bronx, New York, United States, 10461
Status Unknown
69
Jack Weiler Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10465
Status Unknown
70
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
71
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States, 10467
Status Unknown
72
North Central Bronx Hosp / Bronx Municipal Hosp
The Bronx, New York, United States, 10467
Status Unknown
73
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States, 10468
Status Unknown
74
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
75
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States, 27401
Status Unknown
76
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
77
Univ of Kentucky Lexington
Cincinnati, Ohio, United States, 45267
Status Unknown
78
Case Western Reserve Univ
Cleveland, Ohio, United States, 44106
Status Unknown
79
MetroHealth Med Ctr
Cleveland, Ohio, United States, 441091998
Status Unknown
80
Columbus Children's Hosp
Columbus, Ohio, United States, 432052696
Status Unknown
81
Med College of Ohio
Toledo, Ohio, United States, 43699
Status Unknown
82
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
Status Unknown
83
Saint Michael's Med Ctr / Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States, 170330850
Status Unknown
84
Girard Med Ctr
Philadelphia, Pennsylvania, United States, 191046073
Status Unknown
85
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
86
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States, 191075098
Status Unknown
87
Med Univ of South Carolina / UNC
Charleston, South Carolina, United States, 29425
Status Unknown
88
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
89
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States, 37920
Status Unknown
90
Meharry Med College
Nashville, Tennessee, United States, 37203
Status Unknown
91
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
92
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, United States, 77030
Status Unknown
93
Univ of Washington
Seattle, Washington, United States, 981224304
Status Unknown
94
Northern Wisconsin Hemophilia Ctr / Saint Vincent's Hosp
Green Bay, Wisconsin, United States, 54301
Status Unknown
95
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, United States, 532130127
Status Unknown
96
Univ of Puerto Rico
San Juan, Puerto Rico, 009365067
Status Unknown
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
K Henry, A Erice, C Tierney...
https://pubmed.ncbi.nlm.nih.gov/9833742R W Price, C T Yiannoutsos, D B Clifford...
https://pubmed.ncbi.nlm.nih.gov/10509569