A Study of 141W94 in Combination With Other Anti-HIV Drugs

NCT00002372 | Completed Phase 1

• 1 other identifier: 264A
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

To determine the steady-state pharmacokinetics of 141W94 in combination with saquinavir, indinavir and nelfinavir after multiple oral dosing. To determine the steady-state pharmacokinetics of saquinavir, indinavir, and nelfinavir in combination with 141W94 after multiple oral dosing. To assess the safety and tolerability of multiple doses of 141W94 when combined with saquinavir, indinavir and nelfinavir.

Conditions

HIV Infections

Keywords

Drug Therapy, Combination; Administration, Oral; HIV Protease Inhibitors; Indinavir; Saquinavir; Nelfinavir; VX 478

Interventions

Indinavir sulfate DRUG

Amprenavir DRUG

Nelfinavir mesylate DRUG

Saquinavir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed provided used with caution:
• Medications that may interact at CYP3A4 (either a substrate, inhibitor or inducer of the enzyme) should be used with caution.
• Patients must have:
• Documented HIV infection.
• CD4+ cell count \>= 200 cells/mm3.
• \. Anticipated need for treatment with cytotoxic chemotherapeutic agents within the study time period.
• Treatment with immunomodulating agents.
• Medications that should not be administered with 141W94:
• Terfenadine. Astemizole. Cisapride. Triazolam. Midazolam. Ergotamine/Dihydroergotamine-containing regimens. Antiretroviral drugs. Vitamin E supplements. Other experimental agents.
• Anticipated need for radiation therapy within the study time period.
• \. Prior protease inhibitors.
• Antiretroviral therapy within 2 weeks prior to entry.
• Treatment with cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
• Radiation therapy within 4 weeks prior to entry. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing and protocol evaluations.

Sponsors & Collaborators

• Glaxo Wellcome: lead

Study Sites (3)

Univ of California / San Diego Treatment Ctr

San Diego, California, 92103, United States

Location

ViRx Inc

San Francisco, California, 94109, United States

Location

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Eron JJ, Haubrich R, Lang W, Pagano G, Millard J, Wolfram J, Snowden W, Pedneault L, Tisdale M. A phase II trial of dual protease inhibitor therapy: amprenavir in combination with indinavir, nelfinavir, or saquinavir. J Acquir Immune Defic Syndr. 2001 Apr 15;26(5):458-61. doi: 10.1097/00126334-200104150-00008.

  PMID: 11391165 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Indinavir; amprenavir; Nelfinavir; Saquinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1998-11

Locations

US (3)