A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
NCT ID: NCT00000841
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1750 participants
INTERVENTIONAL
1997-06-30
Brief Summary
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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.
Detailed Description
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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. \[AS PER 02/25/97 AMENDMENT: Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy. An open label extension phase has been added for the period through 06/30/97. Patients who had been randomized to AZT/3TC are given the option of continuing on assigned ACTG 320 study drugs, crossing over to open-label indinavir, or permanently discontinuing all study therapies and going off study. Patients who were randomized to AZT/3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies. It is strongly suggested that patients who were on AZT/3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible.\] \[ AS PER 06/06/97 AMENDMENT: The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks (but not beyond 09/30/97). This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual (the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized).\] \[ AS PER 09/15/97 AMENDMENT: Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372.\]
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Lamivudine
Stavudine
Zidovudine
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Hammer SM
Role: STUDY_CHAIR
Squires KE
Role: STUDY_CHAIR
Fischl MA
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Children's Hosp of Los Angeles
Los Angeles, California, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Harbor UCLA Med Ctr
Torrance, California, United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, United States
Howard Univ
Washington D.C., District of Columbia, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, United States
Queens Med Ctr
Honolulu, Hawaii, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Illinois Masonic Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States
Boston Med Ctr
Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York, New York, United States
Manhattan Veterans Administration / New York Univ Med Ctr
New York, New York, United States
Saint Clare's Hosp and Health Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Harlem Hosp Ctr
New York, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States
SUNY / State Univ of New York
Syracuse, New York, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Carolinas Med Ctr
Charlotte, North Carolina, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, United States
Central Prison/Women's Prison in Raleigh / NC
Raleigh, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, United States
Case Western Reserve Univ
Cleveland, Ohio, United States
Columbus Children's Hosp
Columbus, Ohio, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, United States
Meharry Med College
Nashville, Tennessee, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Univ of Texas Galveston
Galveston, Texas, United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, United States
Univ of Washington
Seattle, Washington, United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Reiter G, Wojnarowski C. Low rate of nelfinavir discontinuation in a clinic population. Int Conf AIDS. 1998;12:1049 (abstract no 60273)
ACTG 320 trial halted as three-drug arm proves superior. AIDS Patient Care STDS. 1997 Jun;11(3):194. No abstract available.
Conference updates show promising drug data. AIDS Alert. 1997 Nov;12(11):125-6.
Baker R. 3-drug therapy reduces deaths and new AIDS-related illnesses by 50%. BETA. 1997 Mar:3-4.
Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 4;135(11):954-64. doi: 10.7326/0003-4819-135-11-200112040-00007.
Demeter LM, Bosch RJ, Coombs RW, Fiscus S, Bremer J, Johnson VA, Erice A, Jackson JB, Spector SA, Squires KM, Fischl MA, Hughes MD, Hammer SM. Detection 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. J Clin Microbiol. 2002 Jun;40(6):2089-94. doi: 10.1128/JCM.40.6.2089-2094.2002.
Coplan P, Cook J, Carides G, Nguyen BY, Testa M. Impact of indinavir with zidovudine and lamivudine on quality of life for HIV patients with < or = 200 CD4 in ACTG 320. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:86 (abstract no 101)
Hammer SM, Squires KE, Hughes MD, Grimes JM, Demeter LM, Currier JS, Eron JJ Jr, Feinberg JE, Balfour HH Jr, Deyton LR, Chodakewitz JA, Fischl MA. A 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. N Engl J Med. 1997 Sep 11;337(11):725-33. doi: 10.1056/NEJM199709113371101.
Demeter LM, Degruttola V, Eshleman S, Jackson JB, Hughes M, Hammer SM. Baseline (BL) HIV-1 protease (PR) and reverse transcriptase (RT) genotype as a predictor of response to ZDV+3TC+indinavir (IDV). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:92 (abstract no 131)
Freedberg KA, Goldie SJ, Paltiel AD, Losina E, Cohen CJ, Seage GR, Craven DE, Zhang H, Kimmel AD, Sullivan LM, Weinstein MC. Combination antiretroviral therapy is both effective and cost-effective. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29 (abstract no I-2070)
Levine, AM. HPV Infection and Cervical/Anal Precursor Lesions in the HAART Era. http://www.medscape.com/viewarticle/440151
Coplan PM, Cook JR, Carides GW, Heyse JF, Wu AW, Hammer SM, Nguyen BY, Meibohm AR, DiNubile MJ; AIDS Clinical Trials Group 320 Study Team. Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine. Clin Infect Dis. 2004 Aug 1;39(3):426-33. doi: 10.1086/422520. Epub 2004 Jul 19.
Mrus JM, Williams PL, Tsevat J, Cohn SE, Wu AW. Gender differences in health-related quality of life in patients with HIV/AIDS. Qual Life Res. 2005 Mar;14(2):479-91. doi: 10.1007/s11136-004-4693-z.
Mrus JM, Schackman BR, Wu AW, Freedberg KA, Tsevat J, Yi MS, Zackin R. Variations in self-rated health among patients with HIV infection. Qual Life Res. 2006 Apr;15(3):503-14. doi: 10.1007/s11136-005-1946-4.
Cole SR, Stuart EA. Generalizing evidence from randomized clinical trials to target populations: The ACTG 320 trial. Am J Epidemiol. 2010 Jul 1;172(1):107-15. doi: 10.1093/aje/kwq084. Epub 2010 Jun 14.
Other Identifiers
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11294
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 320
Identifier Type: -
Identifier Source: org_study_id