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A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zidovudine
Didanosine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Didanosine, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule

Eligibility Criteria

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

Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 count >= 550 cells/mm3. Asymptomatic disease. No prior antiretroviral therapy. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical condition that precludes study compliance. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Biologic response modifiers including erythropoietin and G-CSF. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Systemic radiation therapy. Patients with the following prior conditions are excluded: History of grade 2 or worse peripheral neuropathy. History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: Prior antiretrovirals. Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.

Sites / Locations

  • Univ of Alabama at Birmingham
  • San Francisco Gen Hosp
  • Univ of Colorado Health Sciences Ctr
  • Univ of Miami School of Medicine
  • Northwestern Univ Med School
  • Cook County Hosp
  • Rush Presbyterian - Saint Luke's Med Ctr
  • Louis A Weiss Memorial Hosp
  • Illinois Masonic Med Ctr
  • Indiana Univ Hosp
  • Methodist Hosp of Indiana / Life Care Clinic
  • Johns Hopkins Hosp
  • Harvard (Massachusetts Gen Hosp)
  • Brigham and Women's Hosp
  • Jack Weiler Hosp / Bronx Municipal Hosp
  • Beth Israel Med Ctr
  • Bellevue Hosp / New York Univ Med Ctr
  • Univ of Rochester Medical Center
  • Univ of North Carolina
  • Univ of Cincinnati
  • Ohio State Univ Hosp Clinic
  • Univ of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00000823
Brief Title
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
Official Title
A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Bristol-Myers Squibb, Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
To determine the relative antiviral activity and safety of zidovudine ( AZT ) and didanosine ( ddI ) alone and in combination, as well as in various sequences of administration. The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity.
Detailed Description
The relative efficacy of the approved antiretrovirals in early HIV-1 disease is unclear; thus, a study is needed to evaluate the ability of these various nucleoside analogs to limit pathogenicity. Patients undergo observation for 2 weeks, then are randomized to one of six treatment arms to receive ddI alone or in sequence or combination with AZT for 16-32 weeks, followed by 4 weeks of post-treatment evaluation. The regimens are: ddI alone for 32 weeks; AZT for 16 weeks followed by ddI for 16 weeks; AZT for 16 weeks followed by AZT/ddI combination for 16 weeks; ddI for 16 weeks followed by AZT for 16 weeks; AZT/ddI combination for 32 weeks; and placebo for 32 weeks. PER AMENDMENT 6/18/96: NOTE: Patients enrolled under version 3 of the study will terminate treatment at week 16 and have a 4 week follow up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Didanosine, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zidovudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients must have: HIV-1 seropositivity. CD4 count >= 550 cells/mm3. Asymptomatic disease. No prior antiretroviral therapy. Consent of parent or guardian if less than 18 years old. PER AMENDMENT 6/18/96: Patients with an undocumented history of oral candidiasis or a history of candidiasis that was antibiotic associated may enroll. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical condition that precludes study compliance. Concurrent Medication: Excluded: Antiretrovirals other than study drugs. Biologic response modifiers including erythropoietin and G-CSF. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Systemic radiation therapy. Patients with the following prior conditions are excluded: History of grade 2 or worse peripheral neuropathy. History of pancreatitis or factors predisposing to pancreatitis. Prior Medication: Excluded: Prior antiretrovirals. Systemic immunomodulators (e.g., gp120, gp160, IL-2, interferons) within 3 months prior to study entry. Chronic alcoholism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Collier AC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Johnson V
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
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
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rush Presbyterian - Saint Luke's Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Louis A Weiss Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Illinois Masonic Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606575147
Country
United States
Facility Name
Indiana Univ Hosp
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
Methodist Hosp of Indiana / Life Care Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Harvard (Massachusetts Gen Hosp)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Jack Weiler Hosp / Bronx Municipal Hosp
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Facility Name
Beth Israel Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997215
Country
United States
Facility Name
Univ of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
452670405
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Univ of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981224304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multicenter Phase II Double-Blind Exploratory Study to Evaluate Differences Among Various Zidovudine/Didanosine Regimens on Quantitative Measures of Viral Burden in Relatively Early HIV-1 Infection

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