AzTrials
AzTrials

HIV InfectionsPhase 3NCT00000841

A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months

A Phase 3 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 87 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Indinavir sulfate, Lamivudine and Stavudine
How many people
1,750 participants
Where
87 sitesin 2 countries
Study dates
Start not givento Jun 1997
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Required:
  • PCP prophylaxis.
  • Allowed:
  • Topical or oral antifungal agents (other than oral ketoconazole).
  • Approved agents for opportunistic infections.
Show all 20Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.

Trial locations and contacts

87 sites in 2 countries.

87 sites in 2 countries

United States85 sites

  • Emory Univ

    Atlanta, Georgia, 30308

  • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

    Atlanta, Georgia, 303652225

  • State of MD Div of Corrections / Johns Hopkins Univ Hosp

    Baltimore, Maryland, 212052196

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Louis A Weiss Memorial Hosp

    Chicago, Illinois, 60640

  • Illinois Masonic Med Ctr

    Chicago, Illinois, 606575147

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Univ of Kentucky Lexington

    Cincinnati, Ohio, 45267

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • Columbus Children's Hosp

    Columbus, Ohio, 432052696

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Kaiser Permanente Franklin Med Ctr

    Denver, Colorado, 80262

  • Mountain States Reg Hemo Ctr / Univ of Colorado

    Denver, Colorado, 80262

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Texas Galveston

    Galveston, Texas, 775550435

  • North Shore Univ Hosp

    Great Neck, New York, 11021

  • Moses H Cone Memorial Hosp

    Greensboro, North Carolina, 27401

  • Milton S Hershey Med Ctr

    Hershey, Pennsylvania, 170330850

  • Queens Med Ctr

    Honolulu, Hawaii, 96816

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Univ Texas Health Science Ctr / Univ Texas Med School

    Houston, Texas, 77030

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Division of Inf Diseases/ Indiana Univ Hosp

    Indianapolis, Indiana, 46202

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana, 46202

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa, 52242

  • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

    Knoxville, Tennessee, 37920

  • Children's Hosp of Los Angeles

    Los Angeles, California, 90027

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • Hennepin County Med Clinic

    Minneapolis, Minnesota, 55415

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Meharry Med College

    Nashville, Tennessee, 37203

  • Vanderbilt Univ Med Ctr

    Nashville, Tennessee, 37203

  • Charity Hosp / Tulane Univ Med School

    New Orleans, Louisiana, 70112

  • Tulane Med Ctr Hosp

    New Orleans, Louisiana, 70112

  • Tulane Univ School of Medicine

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Kaplan Cancer Ctr / New York Univ Med Ctr

    New York, New York, 10016

  • Manhattan Veterans Administration / New York Univ Med Ctr

    New York, New York, 10016

  • Saint Clare's Hosp and Health Ctr

    New York, New York, 10019

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York, 10021

  • St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr / Hemophilia Treatment Ctr

    New York, New York, 10029

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Harlem Hosp Ctr

    New York, New York, 10037

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 191075098

  • Central Prison/Women's Prison in Raleigh / NC

    Raleigh, North Carolina, 276260540

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • St Paul Ramsey Med Ctr

    Saint Paul, Minnesota, 55101

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • San Francisco AIDS Clinic / San Francisco Gen Hosp

    San Francisco, California, 941102859

  • San Francisco Gen Hosp

    San Francisco, California, 941102859

  • Stanford at Kaiser / Kaiser Permanente Med Ctr

    San Francisco, California, 94115

  • Univ of Washington

    Seattle, Washington, 981224304

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St Louis, Missouri, 63112

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

  • SUNY / State Univ of New York

    Syracuse, New York, 13210

  • Montefiore Med Ctr Adolescent AIDS Program

    The Bronx, New York, 10467

  • Bronx Veterans Administration / Mount Sinai Hosp

    The Bronx, New York, 10468

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • George Washington Univ / Hershey Med Ctr

    Washington D.C., District of Columbia, 20037

  • Georgetown Univ Hosp

    Washington D.C., District of Columbia, 20037

  • Howard Univ

    Washington D.C., District of Columbia, 20059

  • Great Lakes Hemophilia Foundation

    Wauwatosa, Wisconsin, 532130127

  • Julio Arroyo

    West Columbia, South Carolina, 29169

  • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial

    Worcester, Massachusetts, 01605

Other trials in United States

Puerto Rico2 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Univ of Puerto Rico

    San Juan, 009365067

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the detailed description

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.]

Conditions
HIV Infections
Being tested
Indinavir sulfate, Lamivudine, Stavudine, Zidovudine
Keywords
Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Antiviral Agents, Zidovudine, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionJun 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Enrolment
1,750 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000841
Sponsor's protocol ID
ACTG 320
Other IDs
11294
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 11361796

  • Conference updates show promising drug data. AIDS Alert. 1997 Nov;12(11):125-6.

    PubMed 11364769

  • Baker R. 3-drug therapy reduces deaths and new AIDS-related illnesses by 50%. BETA. 1997 Mar:3-4.

    PubMed 11364527

  • 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.

    PubMed 11730396

  • 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.

    PubMed 12037070

  • 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.

    PubMed 9287227

  • 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.

    PubMed 15307012

  • 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.

    PubMed 15892437

  • 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.

    PubMed 16547789

  • 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.

    PubMed 20547574

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Indinavir sulfate, Lamivudine and Stavudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 87 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000841, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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