A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination with Two Other Anti-HIV Drugs

This study is currently recruiting patients.

Sponsored by

Glaxo Wellcome

Purpose

The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks. You will be assigned randomly (like tossing a coin) to 1 of 2 groups for 24 weeks of treatment. Group 1 receives 3TC once daily plus d4T plus either IDV or NFV. Group 2 receives 3TC twice daily plus d4T plus either IDV or NFV. Both groups will receive the same total daily dose of 3TC. You will have clinic visits periodically to monitor your body's response to the drugs and your ability to take your medication as scheduled. You may be eligible for this study if you: Are HIV-positive. Are at least 18 years old. Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry. Have a CD4 cell count of at least 50 cells/mm3. Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be your first anti-HIV drug regimen.) Agree to abstain from sex or use effective methods of birth control during the study. You will not be eligible for this study if you: Have a history of an AIDS-defining illness or certain other medical conditions. Are allergic to any of the study drugs. Are unable to take medication by mouth for any reason. Have received certain medications. Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study. Are pregnant or breast-feeding.

Study Type and Design: Treatment; Open Label, Random Allocation

Official Title: A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 mg BID versus Epivir 300 mg Once-Daily when Administered for 24 Weeks in Combination with FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects with HIV-1 Infection

Further Study Details: To compare the efficacy of lamivudine (3TC) administered once daily (qd) vs twice daily (bid) in combination with FDA-approved dosing regimens of stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.  Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.  

Eligibility

Ages Eligible for Study:  18 Years  and above ,  Genders Eligible for Study:  Both Inclusion Criteria

Patients must have: 1. Documented HIV-1 infection. 2. HIV-1 RNA level below 400 copies/ml (by Roche Amplicor assay) for at least the last 3 months of therapy prior to enrollment in this study. 3. CD4+ cell count of at least 50 cells/mm3.

Required: Currently receiving an antiretroviral regimen containing 3TC and FDA-approved dosing regimens of both d4T and either IDV or NFV for at least 6 months prior to study enrollment. This must be the patient's first antiretroviral treatment regimen. Allowed: Patients who have required a change in initial protease inhibitor (PI) therapy due to intolerance (not treatment failure) but who have been on a stable regimen of the second PI therapy for at least 6 months prior to study enrollment.

Allowed: 1. Inhaled corticosteroids for asthmatic patients. 2. Hematological supportive therapy with G-CSF, GM-CSF, or erythropoietin. 3. Local chemotherapy for Kaposi's sarcoma. Recommended: Appropriate chemoprophylaxis for HIV-associated conditions.

Allowed: Local radiation treatment for Kaposi's sarcoma.

Not breast-feeding

Abstinence or effective method of birth control / contraception including oral contraceptives during the study

Not pregnant

Absolute Neutrophil Count >= 1000 cells/mm3

CD4 >= 50 cells/mm3

Creatinine Clr >= 50 ml/min

Hemoglobin Men: >= 10.0 g/dl; women: >= 9.0 g/dl.

Pancreatic Amylase <= 1.5 x ULN ULN (Upper Limit of Normal)

Platelet Count >= 75000 /mm3

SGPT(ALT) <= 5 x ULN

SGOT(AST) <= 5 x ULN

Exclusion Criteria

Patients with the following prior conditions are excluded: 1. History of clinical AIDS-defining indicator illness. 2. History of bilateral peripheral neuropathy of at least Grade 2. 3. History of allergy to any of the study drugs or any excipients therein.

Patients with the following symptoms or conditions are excluded: Malabsorption syndrome or other gastrointestinal dysfunction which may interfere with drug absorption or render the patient unable to take oral medication.

Excluded: 1. Immunomodulating agents, such as systemic corticosteroids, interleukins, vaccines, or interferons within 4 weeks prior to study entry. 2. HIV-1 immunotherapeutic vaccine within 3 months prior to entry.

Excluded: 1. Other antiretroviral drugs, or concurrent enrollment in 1 or more investigational drug protocols other than this study. 2. Cytotoxic chemotherapy. 3. Foscarnet, hydroxyurea, or other agents with documented activity against HIV-1 in vitro. 4. Immunomodulators. Avoid: Neurotoxic drugs.

Excluded: Radiation therapy.

Location and Contact Information

California

Palo Alto Veterans Administration Health Care System, 3801 Miranda Ave (119)   Palo Alto,   California,    94304,   United States; Recruiting

Dr. Mark Holodniy       650-852-3408    mark.holodniy@med.va.gov 

California

AIDS Healthcare Foundation, 1300 North Vermont Ave / Suite 606   Los Angeles,   California,    90027,   United States; Recruiting

Dr Charles Farthing       213-913-3953   

District of Columbia

Dupont Circle Physicians Group, 1737 20th St NW   Washington,   District of Columbia,   20009,    United States; Recruiting

Douglas Ward       202-745-0201   

Florida

North Broward Hosp District, 300 Southeast 17th St   Fort Lauderdale,   Florida,   33316,    United States; Recruiting

Michael Sension       954-467-3006   

Florida

Steinhart Medical Associates, 3659 South Miami Ave / Suite 4006   Miami,   Florida,   33133,    United States; Recruiting

Corklin Steinhart       305-856-2171   

Florida

IDC Research Initiative, 499 East Central Parkway   Altamonte Springs,   Florida,   32701,    United States; Recruiting

Jeff Goodgame, MD       407-647-3960   

Illinois

Northwestern Univ Med School, 303 E Superior St   Chicago,   Illinois,   60611,    United States; Recruiting

Robert Murphy       312-908-0949   

New York

Saint Luke's - Roosevelt Hosp Ctr, 432 West 58th St / Antenucci Building / Lobby Level   New York,   New York,   10019,   United States; Recruiting

Dr George McKinley       212-523-6583   

New York

Saint Vincents Hosp, 412 Sixth Ave / Suite 401   New York,   New York,   10011,    United States; Recruiting

Peter Tsang       212-604-8319   

Pennsylvania

MCP Hahnemann Univ Hosp, Broad and Vine Sts   Philadelphia,   Pennsylvania,   19102,    United States; Recruiting

Arthur "Landis" Osbourne       215-762-3251   

Texas

Univ TX Galveston Med Branch, Route H-82 / Clay Hall / Room 218   Galveston,   Texas,   77550,    United States; Recruiting

Dr Richard Pollard       409-772-4979   

Texas

Southwest Infectious Disease Association / PA, 8226 Douglas Ave / Suite 311   Dallas,   Texas,    75225,   United States; Recruiting

Nicholoas Bellos       214-890-7943   

More Information

Study ID Numbers  225C;  COLA 4005

NLM Identifier  NCT00002442

Date study started June 1, 1999

Recruitment status verified  December 8, 1999

Last Updated  August 6, 1999

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