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A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atevirdine mesylate
Zidovudine
Sponsored by
Pharmacia and Upjohn
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 Concurrent Medication: Allowed: Primary or secondary prophylaxis for opportunistic infections. Patients must have: HIV infection. Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED: Cryptococcosis Pneumocystis carinii pneumonia Herpes zoster Histoplasmosis CMV Hepatic or renal disease Lymphoma. CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry. Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry. Consent of parent, guardian, or person with power of attorney if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Intolerance to AZT. Current diagnosis of malignancy for which systemic therapy will be required during the study. Concurrent Medication: Excluded: Any other investigational drugs. Prior Medication: Excluded: Cytotoxic chemotherapy within 1 month prior to study entry. Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors. Antiretroviral agents other than AZT within 3 months prior to study entry. Required: AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.

Sites / Locations

  • Los Angeles County / Health Research Assoc / Drew Med Ctr
  • UCI Med Ctr
  • Davies Med Ctr
  • Infectious Disease Research Institute Inc
  • Johns Hopkins Hosp
  • Boston City Hosp / FGH-1
  • East Orange Veterans Administration Med Ctr
  • Buckley Braffman Stern Med Associates
  • Mem Hosp of Rhode Island
  • Park Plaza Hosp
  • Univ TX San Antonio Health Science Ctr
  • Wisconsin Community - Based Research Consortium

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Pharmacia and Upjohn
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1. Study Identification

Unique Protocol Identification Number
NCT00002322
Brief Title
A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients
Official Title
Randomized, Double-Blind, Placebo-Controlled Comparative Dose-Response Study of Two Doses of Atevirdine Mesylate (U-87201E) in Combination With Fixed Doses of Zidovudine (AZT) in HIV+ Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 1996
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
Pharmacia and Upjohn

4. Oversight

5. Study Description

Brief Summary
To determine the tolerance and antiviral response of two different doses of atevirdine mesylate (U-87201E) in symptomatic HIV-positive patients with CD4 counts of 50-350 cells/mm3, who also take zidovudine (AZT).
Detailed Description
Patients are randomized to 1 of 3 treatment groups: U-87201E at 1 of 2 doses or placebo administered every 8 hours. Patients must have taken AZT for at least 3 months prior to randomization.

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
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atevirdine mesylate
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Primary or secondary prophylaxis for opportunistic infections. Patients must have: HIV infection. Symptoms (currently or prior to enrollment) included in Category B or C of CDC classification, although THE FOLLOWING CURRENT ACUTE MEDICAL CONDITIONS ARE NOT ALLOWED: Cryptococcosis Pneumocystis carinii pneumonia Herpes zoster Histoplasmosis CMV Hepatic or renal disease Lymphoma. CD4 count 50 - 350 cells/mm3 within 14 days prior to study entry. Ongoing therapy with AZT at 500 - 600 mg total daily dose for at least 3 months prior to study entry. Consent of parent, guardian, or person with power of attorney if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following conditions are excluded: Intolerance to AZT. Current diagnosis of malignancy for which systemic therapy will be required during the study. Concurrent Medication: Excluded: Any other investigational drugs. Prior Medication: Excluded: Cytotoxic chemotherapy within 1 month prior to study entry. Prior U-87201E or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, TIBO R-82150 or TIBO R-82913, L-697639 or L-696229, U-90152S, or any protease inhibitors. Antiretroviral agents other than AZT within 3 months prior to study entry. Required: AZT for at least 3 months prior to study entry. Present use of excessive alcohol or illicit drugs.
Facility Information:
Facility Name
Los Angeles County / Health Research Assoc / Drew Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCI Med Ctr
City
Orange
State/Province
California
ZIP/Postal Code
92668
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Infectious Disease Research Institute Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212052196
Country
United States
Facility Name
Boston City Hosp / FGH-1
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Mem Hosp of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Park Plaza Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Univ TX San Antonio Health Science Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Wisconsin Community - Based Research Consortium
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53202
Country
United States

12. IPD Sharing Statement

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A Study of Different Doses of Atevirdine Mesylate Plus Zidovudine in HIV-Positive Patients

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