Safety and Effectiveness of a Combination Anti-HIV Drug Treatment

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00005018
First received: April 4, 2000
Last updated: June 23, 2005
Last verified: August 2000
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: 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)

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005018

Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Pacific Oaks Research
Beverly Hills, California, United States, 90211
Altamed Medical Health Services
Los Angeles, California, United States, 90022
St Lukes Medical Group
San Diego, California, United States, 92101
Pacific Horizons Med Group
San Francisco, California, United States, 94115
United States, Florida
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
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
Boston Med Ctr / Evans - 556
Boston, Massachusetts, United States, 021182393
CRI of New England
Brookline, Massachusetts, United States, 02445
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

ClinicalTrials.gov Identifier: NCT00005018     History of Changes
Other Study ID Numbers: 238R, NZTA4008
Study First Received: April 4, 2000
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on October 29, 2014