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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Abacavir sulfate (Drug); Lamivudine (Drug); Zidovudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Glaxo Wellcome
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.
Clinical Details
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
Study design: Treatment, Parallel Assignment, Safety Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
San Juan AIDS Program, Santurce 00907, Puerto Rico
East Bay AIDS Ctr, Berkeley, California 94705, United States
Kraus Med Partners, Los Angeles, California 90036, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
Univ of Miami Dept of Medicine, Miami, Florida 33136, United States
Rush Med College / Rush Presbyterian - St Luke's Med Cen, Chicago, Illinois 60612, United States
Boston Med Ctr / Evans - 556, Boston, Massachusetts 021182393, United States
Saint Michael's Med Ctr / Dept of Infectious Diseases, Newark, New Jersey 07102, United States
Harlem Hosp, New York, New York 10027, United States
St Vincent's Hosp and Med Ctr / AIDS Ctr, New York, New York 10011, United States
Duke Univ Med Ctr / Dept of Medicine, Durham, North Carolina 27710, United States
Univ of Cincinnati / Holmes Hosp, Cincinnati, Ohio 452670405, United States
Toronto Gen Hosp, Toronto, Ontario, Canada
Dr Nicholaos Bellos, Dallas, Texas 75225, United States
Baylor College of Medicine / Dept of Medicine, Houston, Texas 770303498, United States
Additional Information
Last updated: June 23, 2005
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