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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Abacavir sulfate; Drug: Ritonavir; Drug: Saquinavir; Drug: Amprenavir; Drug: Indinavir sulfate; Drug: Nelfinavir mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002440

238J

CNAA2004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.