The Safety and Effectiveness of Lamivudine Plus Zidovudine, Used With and Without 1592U89, in HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002389
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
To compare the durability of the viral load response following 48 weeks of treatment with 1592U89/lamivudine (3TC)/zidovudine (ZDV) versus 3TC/ZDV alone. To compare the early antiviral activity following 16 weeks treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone as demonstrated by the proportion of subjects with viral load < 400 copies/ml, plasma HIV-1 RNA profiles and CD4+ profiles. To assess the safety and tolerance following 16 and 48 weeks of treatment with 1592U89/3TC/ZDV versus 3TC/ZDV alone.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Abacavir sulfate Drug: Lamivudine Drug: Zidovudine Phase 3

Detailed Description:
This study compares the safety and efficacy of 1592U89 in combination with 3TC and ZDV versus control therapy with 3TC and ZDV alone. If a patient has two consecutive HIV-1 RNA measurements of >= 400 copies/ml (performed at least one week apart) he or she has the option to switch to open-label therapy with 1592U89/3TC/ZDV, to receive the remaining randomized treatment, or to discontinue study medication. If this criterion is not met, patients continue their randomly assigned therapy until the last patient has completed 48 weeks of therapy. Once patients enter the open-label phase, investigators may add or substitute non-nucleoside reverse transcriptase inhibitors, nucleoside reverse transcriptase inhibitors, or protease inhibitors for 3TC and/or ZDV according to their standard practice once patients enter the open-label phase.

Study Type : Interventional  (Clinical Trial)
Enrollment : 210 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Multicenter Trial to Evaluate the Safety and Efficacy of 1592U89 in Combination With Lamivudine (3TC) and Zidovudine (ZDV) Versus 3TC/ZDV in HIV-1-Infected, Antiretroviral Therapy-Naive Subjects With CD4+ Counts >= 100 Cells/mm3

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MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • Local treatment for Kaposi's sarcoma.
  • Hematologic supportive therapy with GM-CSF, G-CSF, or erythropoietin.

Patients must have:

  • HIV-1 infection as documented by a licensed HIV-1 antibody ELISA and confirmed by either Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.
  • One screening CD4 lymphocyte cell count >= 100 cells/mm3 within 14 days prior to study drug administration.
  • No active or ongoing AIDS-defining opportunistic infection or disease.
  • Signed, informed consent from parent or legal guardian for patients under 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions and symptoms are excluded:

  • Malabsorption syndrome or other gastrointestinal dysfunction that might interfere with drug absorption or render the patient unable to take oral medication.
  • Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction, that, in the opinion of the investigator, would compromise the safety of the patient.

Concurrent Medication:


  • Foscarnet therapy.
  • Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents, or interferons.
  • Cytotoxic chemotherapeutic agents and antioxidants.

Concurrent Treatment:


Radiation therapy.

Patients with the following prior conditions are excluded:

History of clinically relevant pancreatitis or hepatitis within the last 6 months.

Prior Medication:


  • Prior antiretroviral therapy.
  • Vaccination within the past 3 months given as part of an investigational HIV vaccine trial.
  • Chemotherapeutic agents within 30 days of study drug administration.
  • Immunomodulating agents such as systemic corticosteroids, interleukins or interferons, within 30 days of study drug administration.

Prior Treatment:


Radiation therapy within 30 days of study period. Current alcohol or illicit drug use that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002389

United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Kraus Med Partners
Los Angeles, California, United States, 90036
United States, District of Columbia
Georgetown Univ Med Ctr
Washington, District of Columbia, United States, 20007
United States, Florida
Univ of Miami Dept of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Rush Med College / Rush Presbyterian - St Luke's Med Cen
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston Med Ctr / Evans - 556
Boston, Massachusetts, United States, 021182393
United States, New Jersey
Saint Michael's Med Ctr / Dept of Infectious Diseases
Newark, New Jersey, United States, 07102
United States, New York
St Vincent's Hosp and Med Ctr / AIDS Ctr
New York, New York, United States, 10011
Harlem Hosp
New York, New York, United States, 10027
United States, North Carolina
Duke Univ Med Ctr / Dept of Medicine
Durham, North Carolina, United States, 27710
United States, Ohio
Univ of Cincinnati / Holmes Hosp
Cincinnati, Ohio, United States, 452670405
United States, Texas
Dr Nicholaos Bellos
Dallas, Texas, United States, 75225
Baylor College of Medicine / Dept of Medicine
Houston, Texas, United States, 770303498
Canada, Ontario
Toronto Gen Hosp
Toronto, Ontario, Canada
Puerto Rico
San Juan AIDS Program
Santurce, Puerto Rico, 00907
Sponsors and Collaborators
Glaxo Wellcome Identifier: NCT00002389     History of Changes
Other Study ID Numbers: 238D
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: November 1998

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Antiviral Agents
CD4 Lymphocyte Count
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents