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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Abacavir sulfate
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

Eligibility Criteria

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

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.

Sites / Locations

  • Marin County Specialty Clinic
  • Kraus Med Partners
  • ViRx Inc
  • IDC Research Initiative
  • North Broward Hosp District
  • AIDS Research Consortium of Atlanta
  • Univ of Kentucky Med Ctr
  • Beth Israel Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002364
Brief Title
A Study of 1592U89 Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 1997
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 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.
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.

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, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Marin County Specialty Clinic
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Kraus Med Partners
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
ViRx Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

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

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