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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000810
First received: November 2, 1999
Last updated: April 2, 2012
Last verified: April 2012

November 2, 1999
April 2, 2012
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Complete list of historical versions of study NCT00000810 on ClinicalTrials.gov Archive Site
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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)
Randomized, Phase I/II, Dose-Ranging, Open-Label Trial of the Anti-HIV Activity of Delavirdine Mesylate (DLV; U-90,152S)

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
  • Drug: Delavirdine mesylate
  • Drug: Zidovudine
  • Drug: Didanosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
January 1996
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000810
ACTG 260, 11237
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Para M
Study Chair: Fischl M
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP