HIV InfectionsPhase 3NCT00005918
Effectiveness and Safety of Two Forms of Stavudine in HIV-Infected Patients
A Phase 3 study testing Efavirenz, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 77 sites in 17 countries.
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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz, Lamivudine and Stavudine
- How many people
- 730 participants
- Where
- 77 sitesin 17 countries
- Study dates
- Jun 2000to Apr 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
77 sites in 17 countries.
77 sites in 17 countries
United States18 sites
IDC Research Initiative
Altamonte Springs, Florida, 32701
CRI of New England
Brookline, Massachusetts, 02445
The CORE Ctr
Chicago, Illinois, 60612
Aesculapisu Medical Health Group
Dallas, Texas, 75204
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
Med Alternatives
Fort Lauderdale, Florida, 33308
Univ of Texas Med Branch
Galveston, Texas, 775550835
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Plaza Med Ctr
Houston, Texas, 77004
AIDS Healthcare Foundation
Los Angeles, California, 90027
Univ of Louisville
Louisville, Kentucky, 40292
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
Univ Hospital
Oklahoma City, Oklahoma, 73104
No Nevada HOPES
Reno, Nevada, 89520
CRI - Springfield
Springfield, Massachusetts, 01107
Hillsborough County Health Dept
Tampa, Florida, 33602
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Univ of Kansas School of Medicine
Wichita, Kansas, 672143124
Argentina8 sites
Arnaldo Casiro MD
Buenos Aires
Claudia Rodriguez MD
Buenos Aires
Elida Pallone MD
Buenos Aires
Fundacion Huesped
Buenos Aires
Luis Maria Zieher MD
Buenos Aires
Fernando Silva Nieto MD
Prov Bs As
CAICI
Rosario Santa Fe
Marcelo Beltran
San Isidro
Italy8 sites
Reparto Malattie Infettive
Antella
Universita Di Bari
Bari
Ospedali Riuniti
Bergamo
Ospedale Luigi Cacco Moroni
Milan
Ospedale Cotugno
Naples
Ospedale Cisanello
Pisa
Ospedale Amedeo de Savoia
Torino
Ospedale Amedeo di Savoia
Torino
Brazil5 sites
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG
Universidade Estadual de Botucatu
Botucatu-SP
Ricardo Leite Hayden
Santos
Fundacao Zerbini Casa Da Aids
São Paulo
Instituto de Infectologia Emilio Ribas
São Paulo
France5 sites
Hopital Saint Andre
Bordeaux
Hopital Edouard Herriot
Lyon
Hopital De L'Hotel Dieu
Nantes
Srev Du Pr Gentilini
Paris
Hopital Pontachaillou
Rennes
South Africa5 sites
Tygerberg Hosp
Cape Town
Chris Hani Baragwanath Hosp
Johannesburg
Innovir Institute / Saffer House
Johannesburg
Johannesburg Hosp
Johannesburg
Embassy Drive Medical Centre
Pretoria
Canada4 sites
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Dr Roger P Leblanc
Montreal, Quebec
Saint Paul's Hosp
Vancouver, British Columbia
Mexico4 sites
Hospital General
Mexico City
Instituto Nacional de Enfermedades Respiratorias
Mexico City
Instituto Nacional de la Nutricion
Mexico City
Alberto Orneals MD
Tijuana
Spain4 sites
Hosp Clinic
Barcelona
Hosp Gregorio Maranon
Madrid
Hosp son Dureta
Palma de Mallorca
Hosp de Navarra
Pamplona
Portugal3 sites
Hospital Distrital de Almada
Almada
Hospital Universidade De Coimbra
Coimbra
Hosp De Santa Maria
Lisbon
Belgium2 sites
University Hospital Gent
Ghent
Domaine Universitaire Du SART-TILMAN
Liège
Puerto Rico2 sites
San Cristobal Hosp
Coto Laurel, Ponce, 00780
Clinical Research Puerto Rico Inc
San Juan, 009091711
Thailand2 sites
Chulalongkorn Univ Hosp / HIV / NAT Rsch Collab
Bangkok
Bamrasnaradura Hosp
Nontaburi
Location not given1 site
Tan tock Seng Hosp
About this study
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
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).
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Lamivudine, Stavudine
- Keywords
- Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
LamivudineDrug
StavudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startJun 2000
- Primary completionApr 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 730 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005918
- Sponsor's protocol ID
- 244F
- Other IDs
- AI455-099
- Status last verified
- Apr 2011
- First submitted
- 15 Jun 2000
- Last updated
- 4 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005918
- Acronym / sponsor ID
- 244F
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Stavudine, Lamivudine, RNA, Viral, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 730 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efavirenz | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
77 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efavirenz, Lamivudine and Stavudine in people with HIV Infections, run by Bristol-Myers Squibb at 77 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Argentina, Italy, Brazil, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.