Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients

Condition(s) targeted: HIV Infections

Intervention: Efavirenz (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

The purpose of this study is to compare the safety and effectiveness of 2 forms of stavudine (d4T). One form is taken once a day (extended release) and the other form is taken twice a day (immediate release).

Official title: The Safety and Antiviral Efficacy of Stavudine Extended Release Formulation as Compared to Stavudine Immediate Release Formulation, Each as Part of Potent Antiretroviral Combination Therapy

Study design: Treatment, Double-Blind, Safety Study

Detailed description: Patients are randomized to receive blinded stavudine extended release (d4T ER) or immediate release (d4T IR) formulation. Randomization is balanced by screening HIV viral load of less than 30,000 copies/ml or at least 30,000 copies/ml and by site. Patients also receive open-label efavirenz (EFV) and lamivudine (3TC). Efficacy is evaluated over 48 weeks of the dosing period and safety is evaluated over the entire dosing period (56 weeks).

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

Patients may be eligible for this study if they:

- Are at least 18 years old. Patients living in USA, Puerto Rico, Australia, Brazil,

Singapore, and Thailand can be at least 12 years old (need consent of parent or guardian if under 18).

- Have a viral load of at least 2,000 copies/ml within 21 days of study entry.

- Have a CD4 count of at least 100 cells/mm3 within 21 days of study entry.

- Agree to use a barrier method of birth control (such as condoms) during the study.

- Are available for follow-up for at least 56 weeks.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are pregnant or breast-feeding.

- Have taken nonnucleoside reverse transcriptase inhibitors (NNRTIs) or protease

inhibitors (PIs) for more than 30 days and within 14 days of study entry.

- Have a new opportunistic (HIV-related) infection or condition requiring treatment.

- Have acute (early) HIV infection.

- Have diarrhea (at least 6 loose stools/day for at least 7 days in a row) within 30

days prior to study entry.

- Abuse alcohol or drugs.

- Have active hepatitis within 30 days prior to study entry.

- Have a history of peripheral neuropathy (a condition affecting the nervous system).

- Cannot take medications by mouth.

- Are allergic to certain antiviral drugs.

- Need to take certain medications that should not be taken with EFV.

- Have certain other conditions or prior treatments that might affect the study.

CAICI, Rosario Santa Fe, Argentina

Arnaldo Casiro MD, Buenos Aires, Argentina

Fundacion Huesped, Buenos Aires, Argentina

Elida Pallone MD, Buenos Aires, Argentina

Luis Maria Zieher MD, Buenos Aires, Argentina

Fernando Silva Nieto MD, Prov Bs As, Argentina

Claudia Rodriguez MD, Buenos Aires, Argentina

Marcelo Beltran, San Isidro, Argentina

Prahran Market Clinic, South Yarra, Australia

Hugo Ree MD, Brisbane, Australia

University Hospital Gent, Gent, Belgium

Domaine Universitaire Du SART-TILMAN, Liege, Belgium

Fundacao Zerbini Casa Da Aids, Sao Paulo, Brazil

Ricardo Leite Hayden, Santos, Brazil

Federal University of Minas, Dept. of Pediatrics, Belo Horizonte-MG, Brazil

Universidade Estadual de Botucatu, Botucatu-SP, Brazil

Instituto de Infectologia Emilio Ribas, Sao Paulo, Brazil

Hopital Saint Andre, Bordeaux, France

Hopital Edouard Herriot, Lyon Cedex 03, France

Hopital De L'Hotel Dieu, Nantes, France

Srev Du Pr Gentilini, Paris Cedex 13, France

Hopital Pontachaillou, Rennes, France

Sheba Med Ctr, Tel Hashomer, Israel

Kaplan Med Ctr, Rehovot, Israel

Ospedale Luigi Cacco Moroni, Milano, Italy

Reparto Malattie Infettive, Antella, Italy

Ospedale Cotugno, Napoli, Italy

Ospedali Riuniti, Bergamo, Italy

Ospedale Amedeo de Savoia, Torino, Italy

Ospedale Cisanello, Pisa, Italy

Ospedale Amedeo di Savoia, Torino, Italy

Universita Di Bari, Bari, Italy

Instituto Nacional de la Nutricion, Mexico City, Mexico

Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico

Hospital General, Mexico City, Mexico

Alberto Orneals MD, Tijuana, Mexico

Hosp De Santa Maria, Lisboa, Portugal

Hospital Universidade De Coimbra, Coimbra, Portugal

Hospital Distrital de Almada, Almada, Portugal

Clinical Research Puerto Rico Inc, San Juan 009091711, Puerto Rico

San Cristobal Hosp, Coto Laurel, Ponce 00780, Puerto Rico

Federal AIDS Ctr, Moscow, Russian Federation

Nina Volkova MD, St Petersburg, Russian Federation

Tan tock Seng Hosp, Unknown, Singapore

Tygerberg Hosp, Cape Town, South Africa

Johannesburg Hosp, Johannesburg, South Africa

Innovir Institute / Saffer House, Johannesburg, South Africa

Embassy Drive Medical Centre, Pretoria, South Africa

Chris Hani Baragwanath Hosp, Johannesburg, South Africa

Hosp Clinic, Barcelona, Spain

Hosp de Navarra, Pamplona, Spain

Hosp son Dureta, Palma de Mallorca, Spain

Hosp Gregorio Maranon, Madrid, Spain

Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab, Bangkok, Thailand

Bamrasnaradura Hosp, Nontaburi, Thailand

Saint Paul's Hosp, Vancouver, British Columbia, Canada

AIDS Healthcare Foundation, Los Angeles, California 90027, United States

Whitman Walker Clinic, Washington, District of Columbia 20009, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Hillsborough County Health Dept, Tampa, Florida 33602, United States

Med Alternatives, Fort Lauderdale, Florida 33308, United States

The CORE Ctr, Chicago, Illinois 60612, United States

Univ of Kansas School of Medicine, Wichita, Kansas 672143124, United States

Univ of Louisville, Louisville, Kentucky 40292, United States

CRI of New England, Brookline, Massachusetts 02445, United States

CRI - Springfield, Springfield, Massachusetts 01107, United States

No Nevada HOPES, Reno, Nevada 89520, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States

Univ Hospital, Oklahoma City, Oklahoma 73104, United States

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

Dr Roger P Leblanc, Montreal, Quebec, Canada

Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada

Plaza Med Ctr, Houston, Texas 77004, United States

Univ of Texas Med Branch, Galveston, Texas 775550835, United States

Univ of Texas Southwestern Med Ctr, Dallas, Texas 75390, United States

Aesculapisu Medical Health Group, Dallas, Texas 75204, United States

Hampton Roads Med Specialists, Hampton, Virginia 23666, United States

BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: June 2000
Last updated: October 1, 2007