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The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

Primary Purpose

Lymphatic Disease, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Disease focused on measuring Acquired Immunodeficiency Syndrome, Zidovudine

Eligibility Criteria

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

Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas. Other significant, chronic underlying medical illness which would impair study completion. Liver dysfunction as demonstrated by lab results. Laboratory evidence of compromised bone marrow function. Concurrent Medication: Excluded: Any other experimental agents. Any probenecid-containing product. Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following: Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks. Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period. Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period. OR History of secondary infections associated with AIDS related complex (ARC) including: Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years. Herpes zoster infection within 3 years. Oral hairy leukoplakia at any time. OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS. Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I). Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment. Prior Medication: Excluded: - Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT). Excluded within 4 weeks of study entry: - Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy. Excluded within 3 months of study entry: - Antiretroviral drugs or biologic response modifiers. Excluded within 4 months of study entry: - Systemic corticosteroids. Patients must meet the following criteria: HIV infection demonstrated by ELISA and confirmed by Western blot. Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL). Ability to give informed consent. Willingness to be followed by the originating medical center for the entire 3-year duration of the study. Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Sites / Locations

  • LaJolla Veterans Administration Med Ctr
  • AIDS Clinical Trials Group
  • Georgetown Univ Med Ctr
  • Univ of Miami School of Medicine
  • Univ of South Florida
  • Emory Univ School of Medicine
  • Univ of New Mexico Hlth Sciences Ctr / Dept of Med
  • Northshore Hosp / Cornell Univ
  • Nalle Clinic
  • Bowman Gray School of Medicine / North Carolina Baptist Hosp
  • Oregon Health Sciences Univ
  • Good Samaritan Hosp
  • Buckley Braffman Stern Med Associates
  • Graduate Hosp
  • Med Univ of South Carolina
  • Regional Med Ctr at Memphis
  • Univ TX Galveston Med Branch
  • Baylor College of Medicine
  • Dr Kristen Reis
  • Univ of Utah School of Medicine
  • Med College of Virginia
  • Milwaukee County Med Complex

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
NCT00002048
Brief Title
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
Official Title
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
Study Type
Interventional

2. Study Status

Record Verification Date
September 1989
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 evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Disease, HIV Infections
Keywords
Acquired Immunodeficiency Syndrome, Zidovudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas. Other significant, chronic underlying medical illness which would impair study completion. Liver dysfunction as demonstrated by lab results. Laboratory evidence of compromised bone marrow function. Concurrent Medication: Excluded: Any other experimental agents. Any probenecid-containing product. Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following: Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks. Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period. Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period. OR History of secondary infections associated with AIDS related complex (ARC) including: Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years. Herpes zoster infection within 3 years. Oral hairy leukoplakia at any time. OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS. Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I). Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment. Prior Medication: Excluded: - Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT). Excluded within 4 weeks of study entry: - Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy. Excluded within 3 months of study entry: - Antiretroviral drugs or biologic response modifiers. Excluded within 4 months of study entry: - Systemic corticosteroids. Patients must meet the following criteria: HIV infection demonstrated by ELISA and confirmed by Western blot. Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL). Ability to give informed consent. Willingness to be followed by the originating medical center for the entire 3-year duration of the study. Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Facility Information:
Facility Name
LaJolla Veterans Administration Med Ctr
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
AIDS Clinical Trials Group
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Univ of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory Univ School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Northshore Hosp / Cornell Univ
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Nalle Clinic
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Bowman Gray School of Medicine / North Carolina Baptist Hosp
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oregon Health Sciences Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Good Samaritan Hosp
City
Portland
State/Province
Oregon
ZIP/Postal Code
972103079
Country
United States
Facility Name
Buckley Braffman Stern Med Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Graduate Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Regional Med Ctr at Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Dr Kristen Reis
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Univ of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Med College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Milwaukee County Med Complex
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)

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