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.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Efavirenz  Drug: Emtricitabine  Drug: Stavudine  Drug: Didanosine	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  352942050,  United States
California
      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
Colorado
      Univ of Colorado Health Ctr / Denver Gen Hosp, Denver,  Colorado,  80262,  United States
      Beacon Clinic / Boulder Community Hosp, Boulder,  Colorado,  80304,  United States
Connecticut
      Blick Med Associates, Stamford,  Connecticut,  06901,  United States
District of Columbia
      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States
      Physicans Home Service, Washington,  District of Columbia,  20037,  United States
Florida
      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
Georgia
      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
Illinois
      Northstar Med Clinic, Chicago,  Illinois,  60657,  United States
Louisiana
      Tulane Univ Med Ctr / Infectious Diseases Sect, New Orleans,  Louisiana,  70112,  United States
Maryland
      Institute of Human Virology, Baltimore,  Maryland,  21201,  United States
Massachusetts
      New England Med Ctr, Boston,  Massachusetts,  02111,  United States
      Fenway Community Health Ctr, Boston,  Massachusetts,  02115,  United States
Minnesota
      Abbott-Northwestern Hosp / Clinic 42, Minneapolis,  Minnesota,  55404,  United States
New Jersey
      South Jersey Infectious Diseases Inc, Somers Point,  New Jersey,  08244,  United States
New York
      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
Oregon
      Fanno Creek Clinic, Portland,  Oregon,  97219,  United States
Rhode Island
      Paragon Clinical Research, Cranston,  Rhode Island,  02920,  United States
South Carolina
      Coastal Carolina Research Ctr, Mount Pleasant,  South Carolina,  29464,  United States
Texas
      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
Washington
      Swedish Med Ctr / Dr Peter Shalit, Seattle,  Washington,  98104,  United States
Argentina
      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
Canada, British Columbia
      Viridae Clinical Sciences / University of British Columbia, Vancouver,  British Columbia,  Canada
Canada, Ontario
      McMaster Univ Med Centre, Hamilton,  Ontario,  Canada
Canada, Quebec
      Centre De Recherche En Infectiologie, Ste Foy,  Quebec,  Canada
      Montreal Gen Hosp, Montreal,  Quebec,  Canada
Chile
      Fundacion Arriaran, Santiago,  Chile
Mexico
      Instituto Nacional de la Nutricion, Mexico City,  Mexico
Puerto Rico
      San Juan Veterans Administration Med Ctr, San Juan,  009275800,  Puerto Rico

Study ID Numbers:  298C; FTC-301
Record last reviewed:  June 2006
Last Updated:  October 13, 2004
Record first received:  September 11, 2000
ClinicalTrials.gov Identifier:  NCT00006208
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08