HIV InfectionsPhase 3NCT00006208
A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
A Phase 3 study testing Efavirenz, Emtricitabine and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals at 63 sites in 6 countries.
Trial summary
The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz, Emtricitabine and Stavudine
- How many people
- Not given
- Where
- 63 sitesin 6 countries
- Study dates
- Aug 2000to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Are at least 18 years old at the time of screening.
- Have plasma HIV-1 RNA loads (level of HIV in your blood) of 5,000 or more copies/ml at the time of screening.
- Have not used any anti-HIV therapy for more than 2 days.
- Have a negative pregnancy test within 22 days of starting study drugs.
- Can be reached by telephone.
Who cannot join
- Patients will not be eligible for this study if they:
- Are pregnant or breast-feeding.
- Use alcohol or illegal drugs that, in the opinion of the principal investigator, may interfere with the patient's ability to follow the dosing schedule and protocol evaluations.
- Are being treated for active tuberculosis.
- Are using astemizole, cisapride, midazolam, triazolam, ergot derivatives, St. John's wort, or drugs for a mental disorder.
- Have a history of a serious mental disorder.
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- Are unwilling to use an effective barrier method of birth control during the study (for women who can get pregnant).
- Have a history of opportunistic infections and cancers (Mycobacterium avium complex, cytomegalovirus, toxoplasmic encephalitis or disseminated toxoplasmosis, cryptosporidiosis, Isospora belli, progressive multifocal leukoencephalopathy, visceral Kaposi's sarcoma, and lymphoma). Patients with past episode of pulmonary tuberculosis, Pneumocystis carinii pneumonia, or isolated cutaneous Kaposi's sarcoma are allowed. Medication for the prevention of PCP (TMP/SMX, nebulized pentamidine, and atovaquone) is allowed.
- Have peripheral neuropathy (a painful condition affecting the nervous system) or history of peripheral neuropathy.
- Cannot take medicine by mouth or have severe chronic diarrhea within 30 days before beginning the study.
- Cannot eat 1 or more meals a day because of chronic nausea, vomiting, or abdominal or esophageal discomfort.
- Have had a serious illness or injury within 30 days of screening. Treatment must have been completed for 14 days prior to study entry.
- Have a history of AIDS-defining opportunistic infection, except for tuberculosis or infection of the stomach or intestines.
Trial locations and contacts
63 sites in 6 countries.
63 sites in 6 countries
United States51 sites
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309
Central Texas Clinical Research
Austin, Texas, 78705
Institute of Human Virology
Baltimore, Maryland, 21201
East Bay AIDS Ctr
Berkeley, California, 94705
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050
New England Med Ctr
Boston, Massachusetts, 02111
Fenway Community Health Ctr
Boston, Massachusetts, 02115
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304
Erie County Med Ctr
Buffalo, New York, 14215
Northstar Med Clinic
Chicago, Illinois, 60657
East Bay Clinical Trial Ctr
Concord, California, 94520
Paragon Clinical Research
Cranston, Rhode Island, 02920
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219
Amelia Ct Clinic
Dallas, Texas, 75235
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, 80262
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Univ TX Galveston Med Branch
Galveston, Texas, 77555
Houston Clinical Research Network
Houston, Texas, 77006
Diversified Med Practices, PA
Houston, Texas, 77027
Walter Gaman
Irving, Texas, 75038
Mem Med Group Inc
Long Beach, California, 90806
AIDS Healthcare Foundation
Los Angeles, California, 90027
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, 11030
South Miami Hosp
Miami, Florida, 33143
Wohlfeiler, Piperator & King, MD, PA
Miami Beach, Florida, 33139
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, 29464
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, 70112
Dr Lawrence Fontana
New York, New York, 10003
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, 10003
Howard Grossman
New York, New York, 10011
Mount Sinai School of Medicine
New York, New York, 10029
Orange Coast Med Group
Newport Beach, California, 92663
Larry Bush
Palm Springs, Florida, 33461
Fanno Creek Clinic
Portland, Oregon, 97219
Harbin Clinic
Rome, Georgia, 30165
Health Positive
Safety Harbor, Florida, 34695
St Lukes Medical Group
San Diego, California, 92101
Robert Smith Medical Group
San Diego, California, 92103
Saint Francis Mem Hosp / HIV Care
San Francisco, California, 94109
Davies Med Ctr
San Francisco, California, 94114
Infectious Diseases Associates
Sarasota, Florida, 34239
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, 98104
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
Blick Med Associates
Stamford, Connecticut, 06901
Hillsborough County Health Department
Tampa, Florida, 33602
Infectious Disease Research Inst
Tampa, Florida, 33614
Albert Einstein College of Medicine
The Bronx, New York, 10461
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Physicans Home Service
Washington D.C., District of Columbia, 20037
Argentina5 sites
FUNCEI
Buenos Aires
Fundacion HUES
Buenos Aires
Hospital de Agudos JM Ramos Mejia
Buenos Aires
Hospital Muniz
Buenos Aires
Hospital Interzonal Gen de Agudos Oscar Alende
Mar del Plata
Canada4 sites
McMaster Univ Med Centre
Hamilton, Ontario
Montreal Gen Hosp
Montreal, Quebec
Centre De Recherche En Infectiologie
Ste Foy, Quebec
Viridae Clinical Sciences / University of British Columbia
Vancouver, British Columbia
Puerto Rico1 site
San Juan Veterans Administration Med Ctr
San Juan, 009275800
About this study
Official title: A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients
The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Emtricitabine, Stavudine, Didanosine
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Deoxycytidine, 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
EmtricitabineDrug
StavudineDrug
DidanosineDrug
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 startAug 2000
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.
- 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
Sponsor and investigators
- Lead sponsor
- Triangle Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006208
- Sponsor's protocol ID
- 298C
- Other IDs
- FTC-301
- Status last verified
- Jun 2006
- First submitted
- 11 Sep 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Equivalence Trial Comparing Emtricitabine to Stavudine Within a Triple Drug Combination Containing Didanosine Plus Efavirenz in Antiretroviral-Drug Naive HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00006208
- Acronym / sponsor ID
- 298C
- Conditions
- HIV Infections
- Keywords
- HIV-1, Didanosine, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Deoxycytidine, efavirenz
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Triangle PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- 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 emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are at least 18 years old at the time of screening.
- Have plasma HIV-1 RNA loads (level of HIV in your blood) of 5,000 or more copies/ml at the time of screening.
- Have not used any anti-HIV therapy for more than 2 days.
- Have a negative pregnancy test within 22 days of starting study drugs.
- Can be reached by telephone.
Key exclusion criteria (13 listed)
- Are pregnant or breast-feeding.
- Use alcohol or illegal drugs that, in the opinion of the principal investigator, may interfere with the patient's ability to follow the dosing schedule and protocol evaluations.
- Are being treated for active tuberculosis.
- Are using astemizole, cisapride, midazolam, triazolam, ergot derivatives, St. John's wort, or drugs for a mental disorder.
- Have a history of a serious mental disorder.
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 | – |
| Emtricitabine | Drug | – |
| Stavudine | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
63 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efavirenz, Emtricitabine and Stavudine in people with HIV Infections, run by Triangle Pharmaceuticals at 63 sites in 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Argentina, Canada, Chile, Mexico and 1 more country. 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?
Results are not available in the source record.
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 24 Jun 2005.