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
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
1 other identifier
interventional
210
3 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
November 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (15)
East Bay AIDS Ctr
Berkeley, California, 94705, United States
Kraus Med Partners
Los Angeles, California, 90036, United States
Georgetown Univ Med Ctr
Washington D.C., 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
St Vincent's Hosp and Med Ctr / AIDS Ctr
New York, New York, 10011, United States
Harlem Hosp
New York, New York, 10027, 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
Dr Nicholaos Bellos
Dallas, Texas, 75225, United States
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498, United States
Toronto Gen Hosp
Toronto, Ontario, Canada
San Juan AIDS Program
Santurce, 00907, Puerto Rico