Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

June 23, 2005 updated by: Glaxo Wellcome

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Los Angeles, California, United States, 90022
        • Altamed Medical Health Services
      • San Diego, California, United States, 92101
        • St Lukes Medical Group
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Gary Richmond MD
      • Miami, Florida, United States, 331361013
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33607
        • Saint Josephs Comprehensive Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northstar Med Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
    • Massachusetts
      • Boston, Massachusetts, United States, 021182393
        • Boston Med Ctr / Evans - 556
      • Brookline, Massachusetts, United States, 02445
        • CRI of New England
    • Nebraska
      • Omaha, Nebraska, United States, 681985400
        • Univ of Nebraska Medical CTR
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Univ of North Carolina / Infectious Disease Division
      • Wilmington, North Carolina, United States, 28402
        • Univ of NC Infectious Diseases
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19604
        • Anderson Clinical Research Inc
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Burnside Clinic
    • Texas
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77030
        • Univ of Texas / Thomas Street Clinic
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glaxo Wellcome

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion

October 1, 2000

Study Registration Dates

First Submitted

April 4, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 238R
  • NZTA4008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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