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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005918
• Other study ID #: 244F
• Secondary ID: AI455-099
• Status: Completed
• Phase: Phase 3
• First received: June 15, 2000
• Last updated: April 28, 2011
• Start date: June 2000
• Est. completion date: April 2002

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: April 2002
• Est. primary completion date: April 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Lamivudine

• Stavudine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  France,  Israel,  Italy,  Mexico,  Portugal,  Puerto Rico,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand, 

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm