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

NCT ID: NCT00002389

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

HIV Infections

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

Abacavir sulfate

Intervention Type: DRUG

Lamivudine

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaxo Wellcome

INDUSTRY

Sponsor Role: lead

Locations

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

Countries

United States; Canada; Puerto Rico

Other Identifiers

238D

Identifier Type: -

Identifier Source: org_study_id