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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Indinavir sulfate

Amprenavir

Nelfinavir mesylate

Saquinavir

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Administration, Oral, HIV Protease Inhibitors, Indinavir, Saquinavir, Nelfinavir, VX 478

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. 1. 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. 1. 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.

Sites / Locations

Univ of California / San Diego Treatment Ctr
ViRx Inc
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002372

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00002372

Brief Title

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

Official Title

A Phase I/II Screening Trial to Identify Potential Partner Compounds to Use in Combination With 141W94

Study Type

Interventional

2. Study Status

Record Verification Date

November 1998

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Glaxo Wellcome

4. Oversight

5. Study Description

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.

Detailed Description

Patients will be randomized to receive open label 141W94 in combination with saquinavir, indinavir and nelfinavir. The randomized phase will be preceded by a single dose pharmacokinetic interaction study of 141W94 and indinavir in 12 patients. Data from this single dose investigation will be used to determine the dose of indinavir to be used in the randomized phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Indinavir sulfate

Intervention Type

Drug

Intervention Name(s)

Amprenavir

Intervention Type

Drug

Intervention Name(s)

Nelfinavir mesylate

Intervention Type

Drug

Intervention Name(s)

Saquinavir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria 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. 1. 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. 1. 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.

Facility Information:

Facility Name

Univ of California / San Diego Treatment Ctr

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

ViRx Inc

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Facility Name

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

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11391165

Citation

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.

Results Reference

background

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial