Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Effectiveness of a Combination Anti-HIV Drug Treatment
This study has been completed.
First Received: April 4, 2000   Last Updated: June 23, 2005   History of Changes
Sponsored by: Glaxo Wellcome
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00005018
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Hydroxyurea
Drug: Abacavir sulfate
Drug: Efavirenz
Drug: Didanosine
Phase IV

MedlinePlus related topics: AIDS AIDS Medicines
Drug Information available for: Didanosine Abacavir Efavirenz Abacavir sulfate Hydroxyurea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Safety Study
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)

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 150
Study Start Date: July 1999
Estimated Study Completion Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005018

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

No publications provided

Study ID Numbers: 238R, NZTA4008
Study First Received: April 4, 2000
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00005018     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Didanosine
Drug Therapy, Combination
Zidovudine
Stavudine
HIV Protease Inhibitors
Hydroxyurea
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
abacavir
efavirenz

Study placed in the following topic categories:
Antimetabolites
Efavirenz
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Stavudine
Hydroxyurea
Acquired Immunodeficiency Syndrome
Zidovudine
Lamivudine
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors
Virus Diseases
Didanosine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Abacavir
Retroviridae Infections

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hydroxyurea
Hematologic Agents
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections
Antisickling Agents
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Protease Inhibitors
Virus Diseases
Didanosine
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 07, 2009