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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002440
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1998
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Ritonavir
Drug: Abacavir sulfate
Drug: Amprenavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 80
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002440

Locations
United States, California
UCSD Treatment Ctr
San Diego, California, United States, 921036329
United States, Connecticut
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, Connecticut, United States, 065102483
United States, Missouri
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States, 64111
United States, New York
NYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
New York, New York, United States, 10016
United States, North Carolina
Carolinas Med Ctr
Charlotte, North Carolina, United States, 28232
United States, Ohio
Case Western Reserve Univ / AIDS Clinical Trials Unit
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Univ of Pittsburgh Med Ctr
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States, 372321302
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002440     History of Changes
Other Study ID Numbers: 238J, CNAA2004
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
Mutation
HIV-1 Reverse Transcriptase
HIV Protease
Reverse Transcriptase Inhibitors
Anti-HIV Agents
abacavir

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Abacavir
Nelfinavir
HIV Protease Inhibitors
Indinavir
Protease Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on October 19, 2014