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.
Inclusion Criteria
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.
Exclusion Criteria
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.
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
Fundacion Arriaran, Santiago, Chile
Instituto Nacional de la Nutricion, Mexico City, Mexico
San Juan Veterans Administration Med Ctr, San Juan 009275800, Puerto Rico
Univ of Alabama at Birmingham, Birmingham, Alabama 352942050, United States
Viridae Clinical Sciences / University of British Columbia, Vancouver, British Columbia, Canada
Saint Francis Mem Hosp / HIV Care, San Francisco, California 94109, United States
St Lukes Medical Group, San Diego, California 92101, United States
Davies Med Ctr, San Francisco, California 94114, United States
Mem Med Group Inc, Long Beach, California 90806, United States
AIDS Healthcare Foundation, Los Angeles, California 90027, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Orange Coast Med Group, Newport Beach, California 92663, United States
Robert Smith Medical Group, San Diego, California 92103, United States
East Bay Clinical Trial Ctr, Concord, California 94520, United States
Univ of Colorado Health Ctr / Denver Gen Hosp, Denver, Colorado 80262, United States
Beacon Clinic / Boulder Community Hosp, Boulder, Colorado 80304, United States
Blick Med Associates, Stamford, Connecticut 06901, United States
George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States
Physicans Home Service, Washington, District of Columbia 20037, United States
South Miami Hosp, Miami, Florida 33143, United States
Gary Richmond MD, Fort Lauderdale, Florida 33316, 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
Larry Bush, Palm Springs, Florida 33461, United States
Infectious Disease Research Inst, Tampa, Florida 33614, United States
Wohlfeiler, Piperator & King, MD, PA, Miami Beach, Florida 33139, 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
Albert Einstein College of Medicine, Bronx, New York 10461, 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
Mount Sinai School of Medicine, New York, New York 10029, United States
Howard Grossman, New York, New York 10011, United States
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases, New York, New York 10003, United States
Dr Lawrence Fontana, New York, New York 10003, United States
McMaster Univ Med Centre, Hamilton, Ontario, Canada
Fanno Creek Clinic, Portland, Oregon 97219, United States
Centre De Recherche En Infectiologie, Ste Foy, Quebec, Canada
Montreal Gen Hosp, Montreal, Quebec, Canada
Paragon Clinical Research, Cranston, Rhode Island 02920, United States
Coastal Carolina Research Ctr, Mount Pleasant, South Carolina 29464, United States
Univ TX Galveston Med Branch, Galveston, Texas 77555, United States
Houston Clinical Research Network, Houston, Texas 77006, United States
Walter Gaman, Irving, Texas 75038, United States
Nelson Tebedo Health Resource Ctr, Dallas, Texas 75219, United States
Diversified Med Practices, PA, Houston, Texas 77027, United States
Amelia Ct Clinic, Dallas, Texas 75235, United States
Central Texas Clinical Research, Austin, Texas 78705, United States
Swedish Med Ctr / Dr Peter Shalit, Seattle, Washington 98104, United States
