Search / Trial NCT00000841

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Antiviral Agents Zidovudine Stavudine Hiv Protease Inhibitors Lamivudine Indinavir

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...

Gender

All

Eligibility 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.

Attachments

readout_NCT00000841_2024-05-23.pdf

4.5 MB

NCT00000841_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Birmingham, Alabama, United States

Los Angeles, California, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Worcester, Massachusetts, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Miami, Florida, United States

Chicago, Illinois, United States

Great Neck, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Charleston, South Carolina, United States

Bayamon, , Puerto Rico

Los Angeles, California, United States

San Francisco, California, United States

Stanford, California, United States

Stanford, California, United States

Torrance, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Omaha, Nebraska, United States

Bronx, New York, United States

Buffalo, New York, United States

New York, New York, United States

Syracuse, New York, United States

Greensboro, North Carolina, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

Galveston, Texas, United States

San Juan, , Puerto Rico

Charlotte, North Carolina, United States

Los Angeles, California, United States

San Francisco, California, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Denver, Colorado, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Bronx, New York, United States

Hershey, Pennsylvania, United States

Knoxville, Tennessee, United States

Iowa City, Iowa, United States

Minneapolis, Minnesota, United States

Saint Paul, Minnesota, United States

Washington, District Of Columbia, United States

New Orleans, Louisiana, United States

Houston, Texas, United States

Wauwatosa, Wisconsin, United States

Denver, Colorado, United States

New York, New York, United States

Chicago, Illinois, United States

Nashville, Tennessee, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Raleigh, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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