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
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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. |
ClinicalTrials.gov Identifier: NCT00002389 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: June 24, 2005
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Abacavir sulfate Drug: Lamivudine Drug: Zidovudine | Phase 3 |
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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Ages Eligible for Study: | 13 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- 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:
Excluded:
- Foscarnet therapy.
- Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, anti-cytokine agents, or interferons.
- Cytotoxic chemotherapeutic agents and antioxidants.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
History of clinically relevant pancreatitis or hepatitis within the last 6 months.
Prior Medication:
Excluded:
- 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:
Excluded:
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.

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 ClinicalTrials.gov 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 |
ClinicalTrials.gov 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:
HIV-1 Drug Therapy, Combination Antiviral Agents Zidovudine CD4 Lymphocyte Count Lamivudine |
RNA, Viral Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load abacavir |
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 Lamivudine Zidovudine |
Abacavir 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 Antimetabolites |