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Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients Clinical research trials and Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients. Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients  Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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).
Details: 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:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 730
Location and Contact Information:
Embassy Drive Medical Centre
Pretoria, ,
South Africa
Hopital De L'Hotel Dieu
Nantes, ,
France
Tan tock Seng Hosp
Unknown, ,
Singapore
Elida Pallone MD
Buenos Aires, ,
Argentina
Clinique Medicale du Quartier Latin
Montreal, Quebec,
Canada
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
United States
Hugo Ree MD
Brisbane, ,
Australia
IDC Research Initiative
Altamonte Springs, Florida, 32701
United States
Ospedali Riuniti
Bergamo, ,
Italy
Hosp de Navarra
Pamplona, ,
Spain
Prahran Market Clinic
South Yarra, ,
Australia
Saint Luke's - Roosevelt Hosp Ctr
New York City, New York, 10019
United States
Ospedale Amedeo di Savoia
Torino, ,
Italy
Univ of Texas Med Branch
Galveston, Texas, 775550835
United States
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte MG, ,
Brazil
Ospedale Cisanello
Pisa, ,
Italy
San Cristobal Hosp
Coto Laurel, Ponce, , 00780
Puerto Rico
Saint Paul's Hosp
Vancouver, British Columbia,
Canada
University Hospital Gent
Gent, ,
Belgium
No Nevada HOPES
Reno, Nevada, 89520
United States
Ospedale Cotugno
Napoli, ,
Italy
Reparto Malattie Infettive
Antella, ,
Italy
Claudia Rodriguez MD
Buenos Aires, ,
Argentina
Luis Maria Zieher MD
Buenos Aires, ,
Argentina
Sheba Med Ctr
Tel Hashomer, ,
Israel
Innovir Institute / Saffer House
Johannesburg, ,
South Africa
Aesculapisu Medical Health Group
Dallas, Texas, 75204
United States
Universidade Estadual de Botucatu
Botucatu-SP, ,
Brazil
Hospital Distrital de Almada
Almada, ,
Portugal
Tygerberg Hosp
Cape Town, ,
South Africa
Plaza Med Ctr
Houston, Texas, 77004
United States
Ricardo Leite Hayden
Santos, ,
Brazil
Kaplan Med Ctr
Rehovot, ,
Israel
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
United States
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
Bangkok, ,
Thailand
Hampton Roads Med Specialists
Hampton, Virginia, 23666
United States
Srev Du Pr Gentilini
Paris Cedex 13, ,
France
Marcelo Beltran
San Isidro, ,
Argentina
Johannesburg Hosp
Johannesburg, ,
South Africa
CRI of New England
Brookline, Massachusetts, 02445
United States
Med Alternatives
Ft. Lauderdale, Florida, 33308
United States
AIDS Healthcare Foundation
Los Angeles, California, 90027
United States
CAICI
Rosario Santa Fe, ,
Argentina
Fundacion Huesped
Buenos Aires, ,
Argentina
Hopital Saint Andre
Bordeaux, ,
France
Hopital Edouard Herriot
Lyon Cedex 03, ,
France
Alberto Orneals MD
Tijuana, ,
Mexico
Instituto Nacional de la Nutricion
Mexico City, ,
Mexico
Hospital General
Mexico City, ,
Mexico
CRI - Springfield
Springfield, Massachusetts, 01107
United States
The CORE Ctr
Chicago, Illinois, 60612
United States
Hopital Pontachaillou
Rennes, ,
France
Ospedale Amedeo de Savoia
Torino, ,
Italy
Domaine Universitaire Du SART-TILMAN
LIEGE, ,
Belgium
Hosp son Dureta
Palma de Mallorca, ,
Spain
Fernando Silva Nieto MD
Prov Bs As, ,
Argentina
Instituto Nacional de Enfermedades Respiratorias
Mexico City, ,
Mexico
Univ of Louisville
Louisville, Kentucky, 40292
United States
Instituto de Infectologia Emilio Ribas
Sao Paulo, ,
Brazil
Fundacao Zerbini Casa Da Aids
Sao Paulo, ,
Brazil
Hosp Clinic
Barcelona, ,
Spain
Clinique Medicale L'Actuele
Montreal, Quebec,
Canada
Universita Di Bari
Bari, ,
Italy
Nina Volkova MD
St Petersburg, ,
Russian Federation
Clinical Research Puerto Rico Inc
San Juan, , 009091711
Puerto Rico
Hillsborough County Health Dept
Tampa, Florida, 33602
United States
Arnaldo Casiro MD
Buenos Aires, ,
Argentina
Dr Roger P Leblanc
Montreal, Quebec,
Canada
Federal AIDS Ctr
Moscow, ,
Russian Federation
Bamrasnaradura Hosp
Nontaburi, ,
Thailand
Hosp Gregorio Maranon
Madrid, ,
Spain
Chris Hani Baragwanath Hosp
Johannesburg, ,
South Africa
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
United States
Hospital Universidade De Coimbra
Coimbra, ,
Portugal
Ospedale Luigi Cacco Moroni
Milano, ,
Italy
Univ Hospital
Oklahoma City, Oklahoma, 73104
United States
Hosp De Santa Maria
Lisboa, ,
Portugal
Additional Information:
Study ID Numbers: 244F; AI455-099
Study Start Date: June 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005918
Other Hiv Infections Studies:
1. Safety and efficacy of BAY 50-4798 in patients with HIV infection
2. A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
3. A Phase I Trial of Tecogalan sodium ( DS-4152 ) Administered as an Infusion Twice Weekly for 21 Days.
4. Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
5. A Phase I Safety and Immunogenicity Trial of UBI Multivalent HIV-1 Peptide Immunogen in HIV-1 Seronegative Human Subjects
Related Studies:
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Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
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