A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
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
2 other identifiers
interventional
1,750
2 countries
87
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv-infections
87 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
June 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- +5 more criteria
You may not qualify if:
- 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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (87)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Children's Hosp of Los Angeles
Los Angeles, California, 90027, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Harbor UCLA Med Ctr
Torrance, California, 90502, United States
Kaiser Permanente Franklin Med Ctr
Denver, Colorado, 80262, United States
Mountain States Reg Hemo Ctr / Univ of Colorado
Denver, Colorado, 80262, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
George Washington Univ / Hershey Med Ctr
Washington D.C., District of Columbia, 20037, United States
Georgetown Univ Hosp
Washington D.C., District of Columbia, 20037, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
Atlanta, Georgia, 303652225, United States
Queens Med Ctr
Honolulu, Hawaii, 96816, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640, United States
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242, United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112, United States
Tulane Med Ctr Hosp
New Orleans, Louisiana, 70112, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
Baltimore, Maryland, 212052196, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Boston Med Ctr
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
Worcester, Massachusetts, 01605, United States
Hennepin County Med Clinic
Minneapolis, Minnesota, 55415, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 681985130, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
North Shore Univ Hosp
Great Neck, New York, 11021, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Kaplan Cancer Ctr / New York Univ Med Ctr
New York, New York, 10016, United States
Manhattan Veterans Administration / New York Univ Med Ctr
New York, New York, 10016, United States
Saint Clare's Hosp and Health Ctr
New York, New York, 10019, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr / Hemophilia Treatment Ctr
New York, New York, 10029, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY / State Univ of New York
Syracuse, New York, 13210, United States
Montefiore Med Ctr Adolescent AIDS Program
The Bronx, New York, 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Moses H Cone Memorial Hosp
Greensboro, North Carolina, 27401, United States
Central Prison/Women's Prison in Raleigh / NC
Raleigh, North Carolina, 276260540, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Kentucky Lexington
Cincinnati, Ohio, 45267, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Columbus Children's Hosp
Columbus, Ohio, 432052696, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098, United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
Knoxville, Tennessee, 37920, United States
Meharry Med College
Nashville, Tennessee, 37203, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Univ Texas Health Science Ctr / Univ Texas Med School
Houston, Texas, 77030, United States
Univ of Washington
Seattle, Washington, 981224304, United States
Great Lakes Hemophilia Foundation
Wauwatosa, Wisconsin, 532130127, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956, Puerto Rico
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
Related Publications (15)
Reiter G, Wojnarowski C. Low rate of nelfinavir discontinuation in a clinic population. Int Conf AIDS. 1998;12:1049 (abstract no 60273)
BACKGROUNDACTG 320 trial halted as three-drug arm proves superior. AIDS Patient Care STDS. 1997 Jun;11(3):194. No abstract available.
PMID: 11361796BACKGROUNDConference updates show promising drug data. AIDS Alert. 1997 Nov;12(11):125-6.
PMID: 11364769BACKGROUNDBaker R. 3-drug therapy reduces deaths and new AIDS-related illnesses by 50%. BETA. 1997 Mar:3-4.
PMID: 11364527BACKGROUNDDemeter 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.
PMID: 11730396BACKGROUNDDemeter 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.
PMID: 12037070BACKGROUNDCoplan 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)
BACKGROUNDHammer 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.
PMID: 9287227BACKGROUNDDemeter 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)
BACKGROUNDFreedberg 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)
BACKGROUNDLevine, AM. HPV Infection and Cervical/Anal Precursor Lesions in the HAART Era. http://www.medscape.com/viewarticle/440151
BACKGROUNDCoplan 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.
PMID: 15307012BACKGROUNDMrus 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.
PMID: 15892437RESULTMrus 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.
PMID: 16547789RESULTCole 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.
PMID: 20547574RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hammer SM
- STUDY CHAIR
Squires KE
- STUDY CHAIR
Fischl MA