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

Trial Information

Current as of December 05, 2024

Completed

Keywords

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

ClinConnect Summary

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.

Trial Officials

Kuritzkes D

Study Chair

Johnson V

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

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

Discussion 0

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