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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002389
• Date of registration: 02/11/1999
• Primary sponsor: Glaxo Wellcome
• Public title: 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
• Scientific 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
• Date of first enrolment: June 1996
• Target sample size: 210
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002389
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Countries of recruitment

Canada, Puerto Rico, United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Drug: Abacavir sulfate

Drug: Lamivudine

Drug: Zidovudine

Secondary ID(s)

238D

Source(s) of Monetary Support

Please refer to primary and secondary sponsors