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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.]

Study Type

Interventional

Enrollment

1750

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Ramon Ruiz Arnau Univ Hosp / Pediatrics
      • San Juan, Puerto Rico, 009365067
        • Univ of Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Ctr
      • Los Angeles, California, United States, 90027
        • Children's Hosp of Los Angeles
      • Los Angeles, California, United States, 900331079
        • Univ of Southern California / LA County USC Med Ctr
      • San Diego, California, United States, 921036325
        • Univ of California / San Diego Treatment Ctr
      • San Francisco, California, United States, 941102859
        • San Francisco AIDS Clinic / San Francisco Gen Hosp
      • San Francisco, California, United States, 94115
        • Stanford at Kaiser / Kaiser Permanente Med Ctr
      • San Francisco, California, United States, 941102859
        • San Francisco Gen Hosp
      • Stanford, California, United States, 943055107
        • San Mateo AIDS Program / Stanford Univ
      • Stanford, California, United States, 943055107
        • Stanford Univ Med Ctr
      • Torrance, California, United States, 90502
        • Harbor UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
      • Denver, Colorado, United States, 80262
        • Mountain States Reg Hemo Ctr / Univ of Colorado
      • Denver, Colorado, United States, 80262
        • Kaiser Permanente Franklin Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard Univ
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ / Hershey Med Ctr
      • Washington, District of Columbia, United States, 20037
        • Georgetown Univ Hosp
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
      • Miami, Florida, United States, 33161
        • Univ of Miami (Pediatric)
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
      • Atlanta, Georgia, United States, 303652225
        • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ of Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Queens Med Ctr
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med School
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 606143394
        • Chicago Children's Memorial Hosp
      • Chicago, Illinois, United States, 60640
        • Louis A Weiss Memorial Hosp
      • Chicago, Illinois, United States, 606575147
        • Illinois Masonic Med Ctr
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ Hosp
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hosp of Indiana / Life Care Clinic
      • Indianapolis, Indiana, United States, 46202
        • Division of Inf Diseases/ Indiana Univ Hosp
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ of Iowa Hosp and Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
      • New Orleans, Louisiana, United States, 70112
        • Charity Hosp / Tulane Univ Med School
      • New Orleans, Louisiana, United States, 70112
        • Tulane Med Ctr Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
      • Baltimore, Maryland, United States, 212052196
        • State of MD Div of Corrections / Johns Hopkins Univ Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Harvard (Massachusetts Gen Hosp)
      • Boston, Massachusetts, United States, 02118
        • Boston Med Ctr
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - West Campus
      • Worcester, Massachusetts, United States, 01605
        • Worcester Memorial Hosp / Med Ctr of Cntrl MA-Memorial
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Univ of Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Med Clinic
      • Saint Paul, Minnesota, United States, 55101
        • St Paul Ramsey Med Ctr
    • Missouri
      • Saint Louis, Missouri, United States, 63112
        • St Louis Regional Hosp / St Louis Regional Med Ctr
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr
    • New York
      • Bronx, New York, United States, 10468
        • Bronx Veterans Administration / Mount Sinai Hosp
      • Bronx, New York, United States, 10467
        • Montefiore Med Ctr Adolescent AIDS Program
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • Great Neck, New York, United States, 11021
        • North Shore Univ Hosp
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10021
        • Cornell Univ Med Ctr
      • New York, New York, United States, 10016
        • Bellevue Hosp / New York Univ Med Ctr
      • New York, New York, United States, 10021
        • Mem Sloan - Kettering Cancer Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10037
        • Harlem Hosp Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Pediatrics
      • New York, New York, United States, 10021
        • St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
      • New York, New York, United States, 10019
        • Saint Clare's Hosp and Health Ctr
      • New York, New York, United States, 10016
        • Manhattan Veterans Administration / New York Univ Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr / Hemophilia Treatment Ctr
      • New York, New York, United States, 10016
        • Kaplan Cancer Ctr / New York Univ Med Ctr
      • Rochester, New York, United States, 14642
        • Univ of Rochester Medical Center
      • Syracuse, New York, United States, 13210
        • SUNY / State Univ of New York
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Med Ctr
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
      • Greensboro, North Carolina, United States, 27401
        • Moses H Cone Memorial Hosp
      • Raleigh, North Carolina, United States, 276260540
        • Central Prison/Women's Prison in Raleigh / NC
    • Ohio
      • Cincinnati, Ohio, United States, 452670405
        • Univ of Cincinnati
      • Cincinnati, Ohio, United States, 45267
        • Univ of Kentucky Lexington
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
      • Columbus, Ohio, United States, 432052696
        • Columbus Children's Hosp
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 170330850
        • Milton S Hershey Med Ctr
      • Philadelphia, Pennsylvania, United States, 191075098
        • Thomas Jefferson Univ Hosp
    • South Carolina
      • Charleston, South Carolina, United States, 294253312
        • Med Univ of South Carolina
      • West Columbia, South Carolina, United States, 29169
        • Julio Arroyo
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Univ Med Ctr
      • Nashville, Tennessee, United States, 37203
        • Meharry Med College
    • Texas
      • Galveston, Texas, United States, 775550435
        • Univ of Texas Galveston
      • Houston, Texas, United States, 77030
        • Univ Texas Health Science Ctr / Univ Texas Med School
    • Washington
      • Seattle, Washington, United States, 981224304
        • Univ of Washington
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 532130127
        • Great Lakes Hemophilia Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

June 1, 1997

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 320
  • 11294 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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