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Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)

National Institute of Allergy and Infectious Diseases (NIAID) logo

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Completed
Phase 1

Conditions

HIV Infections

Treatments

Drug: Didanosine
Drug: Zidovudine
Drug: Delavirdine mesylate

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000810
ACTG 260
11237 (Registry Identifier)

Details and patient eligibility

About

PRIMARY: To study the safety and tolerance of delavirdine mesylate ( U-90152 ) monotherapy. To compare the anti-HIV activity of three blood concentration levels of this agent with nucleoside analog monotherapy, either zidovudine ( AZT ) or didanosine ( ddI ), based on the reduction of HIV viral burden.

SECONDARY: To use pharmacokinetic parameters to assess the relationship between daily drug exposure and antiviral activity and toxicity of the U-90152, AZT, and ddI monotherapy. To assess anti-HIV activity using other disease markers.

Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.

Full description

Data suggest that bisheteroarylpiperazines (BHAPs) such as delavirdine mesylate are potent and safe anti-HIV agents and may have different biological behavior than other currently available non-nucleoside RT inhibitors.

Patients are randomized to receive U-90152 at one of three doses (treatment arms I through III) or either AZT or ddI (treatment arm IV). Patients on arm IV who are AZT-naive receive AZT; those who are AZT-experienced receive ddI. Treatment continues for 24 weeks.

PER 12/22/94 AMENDMENT: All patients receiving U-90152 have the same starting dose, to attain one of three target trough levels.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • PCP prophylaxis.
  • Topical antifungal agents, clotrimazole troches, nystatin oral suspension, topical ketoconazole, and oral fluconazole.
  • Acyclovir (<= 1000 mg/day) as maintenance therapy for herpes simplex virus.
  • Recombinant erythropoietin and G-CSF.
  • Antibiotics for bacterial infections, unless specifically excluded.
  • Symptomatic treatment such as antipyretics, analgesics, nonsteroidal anti-inflammatory agents, and antiemetics.
  • Antacids.

Patients must have:

  • HIV-1 infection.
  • CD4 count 200 - 500 cells/mm3.
  • Either no prior antiretroviral therapy or discontinued AZT monotherapy 3 or more weeks prior to study entry.

NOTE:

  • Half of patients should be antiretroviral naive.

Prior Medication:

Allowed:

  • Prior AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancy other than minimal Kaposi's sarcoma.

Concurrent Medication:

Excluded:

  • Rifabutin.
  • Rifampin.
  • Terfenadine.
  • Astemizole.
  • Loratadine.
  • Trifluoperazine.
  • Piperazine citrate.
  • Any acute or chronic therapy for CMV, MAC, toxoplasmosis, or disseminated fungal infection.
  • Non-study antiretroviral therapies, interferons, biologic response modifiers, and HIV vaccines.
  • Systemic corticosteroids for more than 21 consecutive days.
  • Foscarnet.
  • Systemic cytotoxic chemotherapy for a malignancy.

Patients with the following prior conditions are excluded:

  • History of pancreatitis (in patients who received prior AZT).
  • History of grade 2 or worse peripheral neuropathy (in patients who received prior AZT).
  • History of hypersensitivity to BHAP compounds (e.g., trifluoperazine - Stelazine, piperazine citrate - Antepar).

Prior Medication:

Excluded within 30 days prior to study entry:

  • Any investigational medication.
  • Interferon.
  • Interleukin.
  • Rifabutin.
  • Rifampin.
  • Terfenadine.
  • Astemizole.
  • Loratadine.
  • Trifluoperazine.
  • Piperazine citrate.

Excluded at any time:

  • Prior ddI, ddC, d4T, or 3TC.
  • Prior foscarnet.
  • Prior BHAP compound or other non-nucleoside RT inhibitor.

Active substance abuse interfering with compliance.

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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