Search / Trial NCT00000882

Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects

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

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Hiv 1 Drug Therapy, Combination Stavudine Hiv Protease Inhibitors Lamivudine Indinavir Rna, Viral Delavirdine Reverse Transcriptase Inhibitors Anti Hiv Agents Viral Load

Description

Although a change in reverse transcriptase (RT) inhibitors is recommended when adding or changing protease inhibitors in a treatment regimen, the choice of available RT inhibitors is often limited by prior exposure, toxicity, or pharmacologic interaction with the protease inhibitors. This study addresses the question of whether to continue 3TC or substitute the nonnucleoside reverse transcriptase inhibitor (NNRTI) DLV when adding IDV to therapy for patients previously treated with ddI or d4T plus 3TC who have greater than 500 copies/ml of plasma HIV-1 RNA. Although the activity of DLV as mo...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Required:
  • Patients completing ACTG 306 who remain on blinded therapy through the extension period or
  • Patients on stable (6 months or greater) ddI/3TC or d4T/3TC combination therapy who have plasma HIV-1 levels higher than 500 copies/ml by the Amplicor HIV-1 Monitor Assay.
  • Allowed following contact with Protocol Pharmacologist:
  • Diltiazem, nifedipine, phenytoin, and warfarin.
  • Patients must have:
  • Absolute CD4 count of 200 cells/mm3 or greater.
  • HIV-1 RNA levels greater than 500 copies/ml by the Amplicor HIV-1 Monitor assay. NOTE:
  • This is a requirement for those receiving study medication. [AS PER AMENDMENT 12/19/97:
  • HIV-1 infection must be documented by any licensed ELISA test kit and confirmed by either Western blot, HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test by a method other than ELISA at any time prior to entry.]
  • Signed, informed consent from a parent or legal guardian for patients under 18 years of age.
  • Life expectancy of at least 24 weeks.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Unexplained temperature of 38.5 C or higher for 7 consecutive days, or chronic diarrhea defined as more than 3 liquid stools per day persisting for 15 days, within 30 days prior to study entry.
  • Proven or suspected acute hepatitis within 30 days prior to study entry.
  • Malignancy that requires systemic chemotherapy. NOTE:Patients with minimal Kaposi's sarcoma (KS) fewer than 5 cutaneous lesions and no visceral disease or tumor-associated edema) are allowed to enroll provided that they do not require systemic therapy.
  • Concurrent Medication:
  • Excluded:
  • Concurrent ZDV (for patients other than those rolling over from ACTG 306).
  • Any experimental antiretroviral agents or other experimental therapies.
  • Acute therapy for an infection or other medical illnesses within 14 days prior to study entry.
  • Recombinant erythropoietin (rEPO), G-CSF, or GM-CSF within 30 days prior to study entry.
  • Interferons, interleukins, or HIV vaccines within 30 days prior to study entry.
  • Rifampin, rifabutin, cisapride, triazolam, midazolam, terfenadine, astemizole, or loratadine, within 14 days prior to study entry.
  • Patients with the following prior conditions are excluded:
  • History of acute or chronic pancreatitis.
  • History of Grade 2 or higher bilateral peripheral neuropathy. [AS PER AMENDMENT 12/19/97: Patients with Grade 2 or 3 peripheral neuropathy due to current use of ddI/3TC or d4T/3TC and who have a screening viral load above 500 copies/ml are eligible as they will be randomized to a regimen that does not contain an agent associated with peripheral neuropathy toxicity.]
  • Prior Medication:
  • Excluded:
  • Prior NNRTI or protease inhibitor therapy.
  • Prior ZDV (for patients other than those rolling over from ACTG 306).
  • Previous induction or maintenance therapy with foscarnet.

Attachments

readout_NCT00000882_2023-12-07.pdf

4.5 MB

NCT00000882_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

Indianapolis, Indiana, United States

New York, New York, United States

Columbus, Ohio, United States

West Columbia, South Carolina, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Seattle, Washington, United States

San Diego, California, United States

Chicago, Illinois, United States

Rochester, New York, United States

Chapel Hill, North Carolina, United States

San Francisco, California, United States

San Jose, California, United States

Stanford, California, United States

Stanford, California, 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

Buffalo, New York, United States

Greensboro, North Carolina, United States

Cleveland, Ohio, United States

Philadelphia, Pennsylvania, United States

San Juan, , Puerto Rico

Charlotte, North Carolina, United States

Denver, Colorado, United States

St Louis, Missouri, 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
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1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
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?

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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