A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
NCT ID: NCT00006208
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
INTERVENTIONAL
2000-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Efavirenz
Emtricitabine
Stavudine
Didanosine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Triangle Pharmaceuticals
INDUSTRY
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham
Birmingham, Alabama, United States
East Bay AIDS Ctr
Berkeley, California, United States
East Bay Clinical Trial Ctr
Concord, California, United States
Mem Med Group Inc
Long Beach, California, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
Orange Coast Med Group
Newport Beach, California, United States
St Lukes Medical Group
San Diego, California, United States
Robert Smith Medical Group
San Diego, California, United States
Saint Francis Mem Hosp / HIV Care
San Francisco, California, United States
Davies Med Ctr
San Francisco, California, United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, United States
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, United States
Blick Med Associates
Stamford, Connecticut, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Physicans Home Service
Washington D.C., District of Columbia, United States
Gary Richmond MD
Fort Lauderdale, Florida, United States
South Miami Hosp
Miami, Florida, United States
Wohlfeiler, Piperator & King, MD, PA
Miami Beach, Florida, United States
Larry Bush
Palm Springs, Florida, United States
Health Positive
Safety Harbor, Florida, United States
Infectious Diseases Associates
Sarasota, Florida, United States
Hillsborough County Health Department
Tampa, Florida, United States
Infectious Disease Research Inst
Tampa, Florida, United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States
Harbin Clinic
Rome, Georgia, United States
Northstar Med Clinic
Chicago, Illinois, United States
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, United States
Institute of Human Virology
Baltimore, Maryland, United States
New England Med Ctr
Boston, Massachusetts, United States
Fenway Community Health Ctr
Boston, Massachusetts, United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States
Erie County Med Ctr
Buffalo, New York, United States
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, United States
Dr Lawrence Fontana
New York, New York, United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, United States
Howard Grossman
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Fanno Creek Clinic
Portland, Oregon, United States
Paragon Clinical Research
Cranston, Rhode Island, United States
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, United States
Central Texas Clinical Research
Austin, Texas, United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, United States
Amelia Ct Clinic
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Diversified Med Practices, PA
Houston, Texas, United States
Walter Gaman
Irving, Texas, United States
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, United States
FUNCEI
Buenos Aires, , Argentina
Fundacion HUES
Buenos Aires, , Argentina
Hospital de Agudos JM Ramos Mejia
Buenos Aires, , Argentina
Hospital Muniz
Buenos Aires, , Argentina
Hospital Interzonal Gen de Agudos Oscar Alende
Mar del Plata, , Argentina
Viridae Clinical Sciences / University of British Columbia
Vancouver, British Columbia, Canada
McMaster Univ Med Centre
Hamilton, Ontario, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
Centre De Recherche En Infectiologie
Ste Foy, Quebec, Canada
Fundacion Arriaran
Santiago, , Chile
Instituto Nacional de la Nutricion
Mexico City, , Mexico
San Juan Veterans Administration Med Ctr
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FTC-301
Identifier Type: -
Identifier Source: secondary_id
298C
Identifier Type: -
Identifier Source: org_study_id