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Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydroxyurea
Abacavir sulfate
Efavirenz
Didanosine
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 HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Hydroxyurea, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

Eligibility Criteria

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

Inclusion Criteria Patients may be eligible for this study if they: Are taking lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). Patients may also be taking one or two protease inhibitors (PIs). (Patients will qualify if drug substitutions were made or if the drugs were stopped for up to 2 months under certain conditions.) Have a viral load of 400 copies/ml or more (treatment failure) after 16 weeks of this treatment. Have a viral load between 400 and 100,000 copies/ml. Have a CD4 cell count of 100 cells/mm3 or more. Have consent of a parent or guardian (if under 18). Agree to use a barrier form of birth control (such as condoms) during the study. Are at least 13 years old. Exclusion Criteria Patients will not be eligible for this study if they: Are unable to take medications by mouth. Have certain opportunistic (AIDS-related) infections or diseases. Have certain serious medical conditions such as diabetes or a disease of the liver, pancreas, or heart. Have a history of lymphoma. Have had peripheral neuropathy (a painful condition affecting the nervous system) within 2 months of study entry. Have been taking anti-HIV drugs for more than 1.5 years without an effect on HIV levels. Have ever taken ABC, ddI, or a type of anti-HIV drug called an NNRTI (such as EFV). Are unable to complete all 48 weeks of the study or take all of the study drugs. Are receiving certain other investigational treatments. Are receiving radiation therapy or chemotherapy within 8 weeks of study entry, or plan to receive one of these treatments during the study. (Local treatment for Kaposi's sarcoma is allowed.) Are taking certain medications including those that might affect the immune system or HIV levels. Have received a vaccine within 8 weeks of study entry or an HIV vaccine within 3 months of study entry. Are pregnant or breast-feeding. Abuse alcohol or drugs.

Sites / Locations

  • East Bay AIDS Ctr
  • Pacific Oaks Research
  • Altamed Medical Health Services
  • St Lukes Medical Group
  • Pacific Horizons Med Group
  • Gary Richmond MD
  • Univ of Miami School of Medicine
  • Saint Josephs Comprehensive Research Institute
  • Northstar Med Clinic
  • Univ of Kentucky Med Ctr
  • Boston Med Ctr / Evans - 556
  • CRI of New England
  • Univ of Nebraska Medical Ctr
  • Beth Israel Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr
  • Univ of North Carolina / Infectious Disease Division
  • Univ of NC Infectious Diseases
  • Anderson Clinical Research Inc
  • Miriam Hosp
  • Burnside Clinic
  • Univ of Texas Med Branch
  • Univ of Texas / Thomas Street Clinic
  • Hampton Roads Med Specialists

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 4, 2000
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00005018
Brief Title
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
Official Title
A Phase IV 48-Week, Randomized, Open-Label, Multicenter Trial of Abacavir (300mg BID)/Efavirenz (600mg QD)/Didanosine (400mg QD) +/- Hydroxyurea (500mg BID) in HIV-1 Infected Subjects Failing Initial Therapy With 3TC/ZDV (or d4T) +/- Protease Inhibitor(s)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if it is safe and effective to give HIV-positive patients a combination of anti-HIV drugs (abacavir [ABC] plus efavirenz [EFV] plus didanosine [ddI]) with and without hydroxyurea (HU).
Detailed Description
Patients are randomized into one of two treatment arms: ABC/EFV/ddI or ABC/EFV/ddI/HU. In the second treatment arm, patients are further randomized to receive HU beginning at Baseline, when ABC/EFV/ddI is started, or at Week 8. Delaying HU may help offset the cytopenic effect of HU, as reflected in a blunted CD4 cell response. Patients are stratified according to their screening plasma HIV-1 RNA level (400 to 10,000 copies/ml and more than 10,000 to 100,000 copies/ml). Participants in the study receive study-related exams, lab tests, and study medications at no cost over the 48-week treatment period. The safety and effectiveness of the non-protease inhibitor rescue therapy is evaluated routinely by measuring viral load and the CD4 cell count, as well as the side effects caused by the medications. All of the medications are approved by the FDA and are not considered investigational.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, Hydroxyurea, RNA, Viral, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, abacavir, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Intervention Type
Drug
Intervention Name(s)
Abacavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
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 may be eligible for this study if they: Are taking lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). Patients may also be taking one or two protease inhibitors (PIs). (Patients will qualify if drug substitutions were made or if the drugs were stopped for up to 2 months under certain conditions.) Have a viral load of 400 copies/ml or more (treatment failure) after 16 weeks of this treatment. Have a viral load between 400 and 100,000 copies/ml. Have a CD4 cell count of 100 cells/mm3 or more. Have consent of a parent or guardian (if under 18). Agree to use a barrier form of birth control (such as condoms) during the study. Are at least 13 years old. Exclusion Criteria Patients will not be eligible for this study if they: Are unable to take medications by mouth. Have certain opportunistic (AIDS-related) infections or diseases. Have certain serious medical conditions such as diabetes or a disease of the liver, pancreas, or heart. Have a history of lymphoma. Have had peripheral neuropathy (a painful condition affecting the nervous system) within 2 months of study entry. Have been taking anti-HIV drugs for more than 1.5 years without an effect on HIV levels. Have ever taken ABC, ddI, or a type of anti-HIV drug called an NNRTI (such as EFV). Are unable to complete all 48 weeks of the study or take all of the study drugs. Are receiving certain other investigational treatments. Are receiving radiation therapy or chemotherapy within 8 weeks of study entry, or plan to receive one of these treatments during the study. (Local treatment for Kaposi's sarcoma is allowed.) Are taking certain medications including those that might affect the immune system or HIV levels. Have received a vaccine within 8 weeks of study entry or an HIV vaccine within 3 months of study entry. Are pregnant or breast-feeding. Abuse alcohol or drugs.
Facility Information:
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Altamed Medical Health Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
St Lukes Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Pacific Horizons Med Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
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
Saint Josephs Comprehensive Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Boston Med Ctr / Evans - 556
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021182393
Country
United States
Facility Name
CRI of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Univ of Nebraska Medical Ctr
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
681985400
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
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Univ of North Carolina / Infectious Disease Division
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Univ of NC Infectious Diseases
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28402
Country
United States
Facility Name
Anderson Clinical Research Inc
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19604
Country
United States
Facility Name
Miriam Hosp
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Burnside Clinic
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29206
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Univ of Texas / Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States

12. IPD Sharing Statement

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Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

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