A Study of 1592U89 in Combination With Protease Inhibitors in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

An Open-Label, Phase II Trial to Evaluate the Steady-State Pharmacokinetics, Safety, and Efficacy of 1592U89 in Combination With Selected HIV-1 Protease Inhibitors in Antiretroviral-Naive, HIV-1-Infected Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002440
• Other study ID #: 238J
• Secondary ID: CNAA2004
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: November 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if it is safe and effective to give 1592U89 plus certain protease inhibitors (PIs) to HIV-infected patients who never have been treated with anti-HIV drugs. This study also examines how the body processes these drugs when they are given together.

Description:

In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Local treatment for Kaposi's sarcoma.

• GM-CSF, G-CSF or erythropoietin.

Patients must have:

• HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture.

• CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration.

• HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration.

• No active or ongoing AIDS-defining opportunistic infection or disease.

• Signed, informed consent from parent or legal guardian for patients less than 18 years of age.

Prior Medication:

Allowed:

Local treatment for Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Malabsorption syndrome, or other gastrointestinal dysfunction, that might interfere with drug absorption or render the patient unable to take oral medication.

• Life-threatening infection or other serious medical condition that may compromise a patient's safety.

Concurrent Medication:

Excluded:

• Other investigational agents. NOTE:

• Those available through Treatment IND or expanded access programs are evaluated individually.

• Chemotherapeutic agents for the initial 24 weeks of study (except local treatment for Kaposi's sarcoma).

• Agents with documented anti-HIV activity in vitro.

• Foscarnet.

• Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents or interferons.

• Antioxidants.

Concurrent Treatment:

Excluded:

Radiation therapy within the first 24 weeks of study.

Patients with the following prior conditions are excluded:

• History of clinically relevant pancreatitis or hepatitis within the last 6 months.

• Participation in an investigational HIV-1 vaccine trial.

Prior Medication:

Excluded:

• Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy.

• Cytotoxic chemotherapeutic agents within 30 days of study drug administration.

• HIV-1 vaccine dose within the 3 months prior to study drug administration.

• Immunomodulating agents, such as systemic corticosteroids, interleukins or interferons within 30 days of study drug administration.

Prior Treatment:

Excluded:

Radiation therapy within 30 days of study drug administration. Alcohol or illicit drug use that may interfere with patient compliance.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Indinavir sulfate

• Ritonavir

• Abacavir sulfate

• Amprenavir

• Nelfinavir mesylate

• Saquinavir

Locations

Country	Name	City	State
United States	Carolinas Med Ctr	Charlotte	North Carolina
United States	Case Western Reserve Univ / AIDS Clinical Trials Unit	Cleveland	Ohio
United States	Kansas City AIDS Research Consortium	Kansas City	Missouri
United States	Vanderbilt Univ Med Ctr	Nashville	Tennessee
United States	Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit	New Haven	Connecticut
United States	NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial	New York	New York
United States	Univ of Pittsburgh Med Ctr	Pittsburgh	Pennsylvania
United States	UCSD Treatment Ctr	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,