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A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months Clinical research trials and A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months. A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months clinical trial. Human subjects often receive the most effective healthcare possible for their A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months  A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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. Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks. Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine ( d4T ) for AZT. Patients are followed at weeks 4, 8, 16, 24, 32, 40, and 48 and every 8 weeks thereafter up to week 96. [AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.] [ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).] [ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.]
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 1750
Location and Contact Information:
Overall Study Official:
HammerSM, Study Chair,
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107
United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030
United States
Columbus Children's Hosp
Columbus, Ohio, 432052696
United States
St Paul Ramsey Med Ctr
St. Paul, Minnesota, 55101
United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202
United States
Meharry Med College
Nashville, Tennessee, 37203
United States
Montefiore Med Ctr Adolescent AIDS Program
Bronx, New York, 10467
United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York City, New York, 10021
United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196
United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York City, New York, 10016
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605
United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Emory Univ
Atlanta, Georgia, 30308
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Howard Univ
Washington D.C., District of Columbia, 20059
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Central Prison/Women's Prison in Raleigh / NC
Raleigh, North Carolina, 276260540
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Univ of Puerto Rico
San Juan, , 009365067
Puerto Rico
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York City, New York, 10029
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
SUNY / State Univ of New York
Syracuse, New York, 13210
United States
Boston Med Ctr
Boston, Massachusetts, 02118
United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267
United States
Manhattan Veterans Administration / New York Univ Med Ctr
New York City, New York, 10016
United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027
United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
San Francisco Gen Hosp
San Francisco, California, 941102859
United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262
United States
Additional Information:
Study ID Numbers: ACTG 320;
Study Start Date:
Record last reviewed: April 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000841
Other Hiv Infections Studies:
1. Measuring HIV Quality of Care
2. Prenatal and Postnatal Studies
3. A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers
4. A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection
5. Determining an Effective Site (Groin versus Arm) for Giving HIV Vaccines
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A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
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