A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
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
2 other identifiers
interventional
N/A
6 countries
63
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 11, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 2006
September 11, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
East Bay AIDS Ctr
Berkeley, California, 94705, United States
East Bay Clinical Trial Ctr
Concord, California, 94520, United States
Mem Med Group Inc
Long Beach, California, 90806, United States
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Orange Coast Med Group
Newport Beach, California, 92663, United States
St Lukes Medical Group
San Diego, California, 92101, United States
Robert Smith Medical Group
San Diego, California, 92103, United States
Saint Francis Mem Hosp / HIV Care
San Francisco, California, 94109, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, 80304, United States
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, 80262, United States
Blick Med Associates
Stamford, Connecticut, 06901, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Physicans Home Service
Washington D.C., District of Columbia, 20037, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
South Miami Hosp
Miami, Florida, 33143, United States
Wohlfeiler, Piperator & King, MD, PA
Miami Beach, Florida, 33139, United States
Larry Bush
Palm Springs, Florida, 33461, United States
Health Positive
Safety Harbor, Florida, 34695, United States
Infectious Diseases Associates
Sarasota, Florida, 34239, United States
Hillsborough County Health Department
Tampa, Florida, 33602, United States
Infectious Disease Research Inst
Tampa, Florida, 33614, United States
Ingenix Kern McNeill Decatur
Atlanta, Georgia, 30309, United States
Infectious Disease Specialists of Atlanta
Decatur, Georgia, 30033, United States
Harbin Clinic
Rome, Georgia, 30165, United States
Northstar Med Clinic
Chicago, Illinois, 60657, United States
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, 70112, United States
Institute of Human Virology
Baltimore, Maryland, 21201, United States
New England Med Ctr
Boston, Massachusetts, 02111, United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115, United States
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, 55404, United States
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244, United States
Erie County Med Ctr
Buffalo, New York, 14215, United States
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, 11030, United States
Dr Lawrence Fontana
New York, New York, 10003, United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, 10003, United States
Howard Grossman
New York, New York, 10011, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Fanno Creek Clinic
Portland, Oregon, 97219, United States
Paragon Clinical Research
Cranston, Rhode Island, 02920, United States
Coastal Carolina Research Ctr
Mt. Pleasant, South Carolina, 29464, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Nelson Tebedo Health Resource Ctr
Dallas, Texas, 75219, United States
Amelia Ct Clinic
Dallas, Texas, 75235, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555, United States
Houston Clinical Research Network
Houston, Texas, 77006, United States
Diversified Med Practices, PA
Houston, Texas, 77027, United States
Walter Gaman
Irving, Texas, 75038, United States
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, 98104, 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, 009275800, Puerto Rico