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
Completed · Phase 3
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002389
- Run by
- Glaxo Wellcome
- People needed
- 210
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
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:
- 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.
Where it is running
- East Bay AIDS Ctr — Berkeley, California, United States
- Kraus Med Partners — Los Angeles, California, United States
- Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
- Univ of Miami Dept of Medicine — Miami, Florida, United States
- Rush Med College / Rush Presbyterian - St Luke's Med Cen — Chicago, Illinois, United States
- Boston Med Ctr / Evans - 556 — Boston, Massachusetts, United States
- Saint Michael's Med Ctr / Dept of Infectious Diseases — Newark, New Jersey, United States
- St Vincent's Hosp and Med Ctr / AIDS Ctr — New York, New York, United States
- Harlem Hosp — New York, New York, United States
- Duke Univ Med Ctr / Dept of Medicine — Durham, North Carolina, United States
- Univ of Cincinnati / Holmes Hosp — Cincinnati, Ohio, United States
- Dr Nicholaos Bellos — Dallas, Texas, United States
- Baylor College of Medicine / Dept of Medicine — Houston, Texas, United States
- Toronto Gen Hosp — Toronto, Ontario, Canada
- San Juan AIDS Program — Santurce, Puerto Rico
Full record on ClinicalTrials.gov
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