A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002364
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1997
  Purpose

To obtain preliminary evidence of antiretroviral activity of 1592U89 when administered in combination with other specific NRTI agents in NRTI experienced patients and to assess the safety and tolerance of multiple oral doses of 1592U89 when administered in combination with specific marketed NRTIs.


Condition Intervention Phase
HIV Infections
Drug: Abacavir sulfate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: An Exploratory Study of the Antiretroviral Activity of 1592U89 When Administered in Combination With Other Specific Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in NRTI Experienced Patients

Resource links provided by NLM:


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

Estimated Enrollment: 40
Detailed Description:

Patients will all receive oral doses of 1592U89 in combination with protocol specific current antiretroviral therapy. The treatment groups will be assigned based on each subject's previous NRTI experience.

The study medication is self administered and all evaluations will be performed on an outpatient basis. Patients will be seen at day 0 and weeks 2, 4, 12, 16, 20 and 24.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must have:

  • CD4+ cell count >= 100 /mm3.
  • Plasma HIV RNA >= 30,000 copies/ml.
  • Study participants may be recruited from all clinical categories, provided they do not meet any of the exclusion criteria.
  • Parent or legal guardian to sign written, informed consent for patients under the age of 18.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

  • Patients with active or ongoing AIDS-defining opportunistic infection or disease. NOTE:
  • For this study, a CD4+ cell count <= 200 cells/mm3 in the absence of any other AIDS defining indicator condition is not considered an AIDS defining event.
  • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption.
  • Patients with life threatening infection or other serious medical conditions whose participation may compromise patient safety.

Concurrent Medication:

Excluded:

  • Treatment with cytotoxic chemotherapeutic agents within the 24 weeks of the study.
  • Patients receiving other investigational drugs.
  • Foscarnet therapy or therapy with other agents with documented activity against HIV in vitro.
  • Treatment with immunomodulators.
  • Patients on methadone.

Concurrent Treatment:

Excluded:

  • Treatment with radiation therapy within the 24 weeks of the study. NOTE:
  • Localized radiation therapy may be permitted following consultation with the sponsor.

Patients with any of the following prior conditions are excluded:

  • Subjects with a history of lymphoma.
  • Subjects with a history of clinically apparent pancreatitis or hepatitis within the last 6 months.

Prior Medication:

Excluded:

  • Treatment with any antiretroviral therapy with NRTIs (alone or in combination) other than those defined for each treatment group.
  • Treatment with any non-nucleoside RT inhibitors or protease inhibitors.
  • Treatment with cytotoxic chemotherapeutic agents within 1 month prior to study entry.
  • Investigational HIV vaccine within the past 3 months.
  • Immunomodulating agents such as systematic corticosteroids, interleukins, thalidomide, anticytokine agents, anti-oxidants or interferons within 1 month of study entry.

Prior Treatment:

Excluded:

  • Treatment with radiation therapy within 1 month of entry.

Risk Behavior:

Excluded:

Patients with current alcohol or illicit drug use that, in the opinion of the principal investigator, may interfere with the patient's ability to comply with the study protocol.

  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: NCT00002364

Locations
United States, California
Marin County Specialty Clinic
Greenbrae, California, United States, 94904
Kraus Med Partners
Los Angeles, California, United States, 90036
ViRx Inc
San Francisco, California, United States, 94109
United States, Florida
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
North Broward Hosp District
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Kentucky
Univ of Kentucky Med Ctr
Lexington, Kentucky, United States, 40536
United States, New York
Beth Israel Med Ctr
New York, New York, United States, 10003
Sponsors and Collaborators
Glaxo Wellcome
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002364     History of Changes
Other Study ID Numbers: 238C, CNAA 2003
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:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

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
Anti-HIV Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014