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

Keywords

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...

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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.