Clinical trial NCT00005918: Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Stavudine
Lamivudine
RNA, Viral
Dosage Forms
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
efavirenz
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 730
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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).

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).

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Washington
country: United States
facility: Whitman Walker Clinic
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: Med Alternatives
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: Wichita
country: United States
facility: Univ of Kansas School of Medicine
state: Kansas
city: Louisville
country: United States
facility: Univ of Louisville
state: Kentucky
city: Brookline
country: United States
facility: CRI of New England
state: Massachusetts
city: Springfield
country: United States
facility: CRI - Springfield
state: Massachusetts
city: Reno
country: United States
facility: No Nevada HOPES
state: Nevada
city: New York
country: United States
facility: Saint Luke's - Roosevelt Hosp Ctr
state: New York
city: Oklahoma City
country: United States
facility: Univ Hospital
state: Oklahoma
city: Dallas
country: United States
facility: Aesculapisu Medical Health Group
state: Texas
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr
state: Texas
city: Galveston
country: United States
facility: Univ of Texas Med Branch
state: Texas
city: Houston
country: United States
facility: Plaza Med Ctr
state: Texas
city: Hampton
country: United States
facility: Hampton Roads Med Specialists
state: Virginia
city: Buenos Aires
country: Argentina
facility: Arnaldo Casiro MD
city: Buenos Aires
country: Argentina
facility: Claudia Rodriguez MD
city: Buenos Aires
country: Argentina
facility: Elida Pallone MD
city: Buenos Aires
country: Argentina
facility: Fundacion Huesped
city: Buenos Aires
country: Argentina
facility: Luis Maria Zieher MD
city: Prov Bs As
country: Argentina
facility: Fernando Silva Nieto MD
city: Rosario Santa Fe
country: Argentina
facility: CAICI
city: San Isidro
country: Argentina
facility: Marcelo Beltran
city: Brisbane
country: Australia
facility: Hugo Ree MD
city: South Yarra
country: Australia
facility: Prahran Market Clinic
city: Gent
country: Belgium
facility: University Hospital Gent
city: Liege
country: Belgium
facility: Domaine Universitaire Du SART-TILMAN
city: Belo Horizonte-MG
country: Brazil
facility: Federal University of Minas, Dept. of Pediatrics
city: Botucatu-SP
country: Brazil
facility: Universidade Estadual de Botucatu
city: Santos
country: Brazil
facility: Ricardo Leite Hayden
city: Sao Paulo
country: Brazil
facility: Fundacao Zerbini Casa Da Aids
city: Sao Paulo
country: Brazil
facility: Instituto de Infectologia Emilio Ribas
city: Vancouver
country: Canada
facility: Saint Paul's Hosp
state: British Columbia
city: Montreal
country: Canada
facility: Clinique Medicale du Quartier Latin
state: Quebec
city: Montreal
country: Canada
facility: Clinique Medicale L'Actuele
state: Quebec
city: Montreal
country: Canada
facility: Dr Roger P Leblanc
state: Quebec
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Lyon Cedex 03
country: France
facility: Hopital Edouard Herriot
city: Nantes
country: France
facility: Hopital De L'Hotel Dieu
city: Paris Cedex 13
country: France
facility: Srev Du Pr Gentilini
city: Rennes
country: France
facility: Hopital Pontachaillou
city: Rehovot
country: Israel
facility: Kaplan Med Ctr
city: Tel Hashomer
country: Israel
facility: Sheba Med Ctr
city: Antella
country: Italy
facility: Reparto Malattie Infettive
city: Bari
country: Italy
facility: Universita Di Bari
city: Bergamo
country: Italy
facility: Ospedali Riuniti
city: Milano
country: Italy
facility: Ospedale Luigi Cacco Moroni
city: Napoli
country: Italy
facility: Ospedale Cotugno
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Torino
country: Italy
facility: Ospedale Amedeo de Savoia
city: Torino
country: Italy
facility: Ospedale Amedeo di Savoia
city: Mexico City
country: Mexico
facility: Hospital General
city: Mexico City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias
city: Mexico City
country: Mexico
facility: Instituto Nacional de la Nutricion
city: Tijuana
country: Mexico
facility: Alberto Orneals MD
city: Almada
country: Portugal
facility: Hospital Distrital de Almada
city: Coimbra
country: Portugal
facility: Hospital Universidade De Coimbra
city: Lisboa
country: Portugal
facility: Hosp De Santa Maria
city: Coto Laurel, Ponce
country: Puerto Rico
facility: San Cristobal Hosp
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
city: Moscow
country: Russian Federation
facility: Federal AIDS Ctr
city: St Petersburg
country: Russian Federation
facility: Nina Volkova MD
city: Cape Town
country: South Africa
facility: Tygerberg Hosp
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hosp
city: Johannesburg
country: South Africa
facility: Innovir Institute / Saffer House
city: Johannesburg
country: South Africa
facility: Johannesburg Hosp
city: Pretoria
country: South Africa
facility: Embassy Drive Medical Centre
city: Barcelona
country: Spain
facility: Hosp Clinic
city: Madrid
country: Spain
facility: Hosp Gregorio Maranon
city: Palma de Mallorca
country: Spain
facility: Hosp son Dureta
city: Pamplona
country: Spain
facility: Hosp de Navarra
city: Bangkok
country: Thailand
facility: Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
city: Nontaburi
country: Thailand
facility: Bamrasnaradura Hosp
facility: Tan tock Seng Hosp
Study officials:
References: