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The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

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

Eligibility Criteria

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

Inclusion Criteria Concurrent Medication: Allowed: Antibiotics for bacterial infections as clinically indicated. Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively. Antipyretics. Analgesics. Allergy medications. Oral contraceptives. Nonprescription medications such as vitamins or herbal therapies. Concurrent Treatment: Allowed: Radiation therapy to local lesion only. Acupuncture. Patients must have: HIV seropositivity. CD4 count >= 550 cells/mm3. No ARC or AIDS conditions by CDC criteria. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of factors predisposing to pancreatitis such as active alcoholism. Other medical conditions that would interfere with study compliance. Concurrent Medication: Excluded: Other antiretrovirals or systemic immunomodulators. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Radiation therapy except to local lesion. Patients with the following prior conditions are excluded: History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month. History of grade 2 or worse peripheral neuropathy. History of pancreatitis. Bacterial infection requiring antibiotics within 14 days prior to study entry. Prior Medication: Excluded: Prior HIV therapy with antiretrovirals or systemic immunomodulators. Prior Treatment: Excluded within 2 weeks prior to study entry: Transfusion. Active substance abuse or alcoholism.

Sites / Locations

  • Hennepin County Med Clinic
  • Univ of Minnesota
  • St Paul Ramsey Med Ctr
  • Univ of Nebraska Med Ctr
  • Case Western Reserve Univ
  • Thomas Jefferson Univ Hosp
  • Univ of Texas Galveston

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001057
Brief Title
The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
Official Title
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of the Virologic Effect of Two Different Nucleoside Treatment Strategies (Zidovudine Versus Zidovudine in Combination With Didanosine) for HIV Infection in Subjects With CD4+ Counts >= 550 Cells/mm3
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
May 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To determine the effects of zidovudine (AZT) alone and in combination with didanosine (ddI) on viral load in the lymphoid tissue and blood of antiretroviral-naive, HIV-infected patients with CD4 counts greater than or equal to 550 cells/mm3. Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period.
Detailed Description
Recent studies have shown that during the asymptomatic phase (clinical latency) of HIV infection, there is an extraordinarily large number of infected CD4+ lymphocytes and macrophages throughout the lymphoid system, both in latent and productive states. These findings support the belief that early intervention therapy with reverse transcriptase inhibitors could prolong the clinical latency period. Patients are randomized to receive AZT alone, AZT plus ddI, or no therapy (placebo) daily for 48 weeks. Patients are followed at weeks 2, 4, and 8, and then every 8 weeks thereafter until week 48.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
105 (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 Concurrent Medication: Allowed: Antibiotics for bacterial infections as clinically indicated. Recombinant erythropoietin (EPO) and G-CSF as clinically indicated for grade 3 or worse anemia and neutropenia, respectively. Antipyretics. Analgesics. Allergy medications. Oral contraceptives. Nonprescription medications such as vitamins or herbal therapies. Concurrent Treatment: Allowed: Radiation therapy to local lesion only. Acupuncture. Patients must have: HIV seropositivity. CD4 count >= 550 cells/mm3. No ARC or AIDS conditions by CDC criteria. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Presence of factors predisposing to pancreatitis such as active alcoholism. Other medical conditions that would interfere with study compliance. Concurrent Medication: Excluded: Other antiretrovirals or systemic immunomodulators. Systemic corticosteroids. Systemic cytotoxic chemotherapy. Intravenous pentamidine. Concurrent Treatment: Excluded: Radiation therapy except to local lesion. Patients with the following prior conditions are excluded: History of chronic diarrhea, defined as more than four loose or watery stools on average daily for the past month. History of grade 2 or worse peripheral neuropathy. History of pancreatitis. Bacterial infection requiring antibiotics within 14 days prior to study entry. Prior Medication: Excluded: Prior HIV therapy with antiretrovirals or systemic immunomodulators. Prior Treatment: Excluded within 2 weeks prior to study entry: Transfusion. Active substance abuse or alcoholism.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erice A
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Balfour H
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carey J
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henry K
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hasse A
Official's Role
Study Chair
Facility Information:
Facility Name
Hennepin County Med Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Univ of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St Paul Ramsey Med Ctr
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Univ of Nebraska Med Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985130
Country
United States
Facility Name
Case Western Reserve Univ
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Thomas Jefferson Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191075098
Country
United States
Facility Name
Univ of Texas Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
775550435
Country
United States

12. IPD Sharing Statement

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The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients

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