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

Patrocinadores

Patrocinador principal: Triangle Pharmaceuticals

Fuente NIH AIDS Clinical Trials Information Service
Resumen breve

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.

Estado general Unknown status
Fecha de inicio August 2000
Fase Phase 3
Tipo de estudio Interventional
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Efavirenz

Tipo de intervención: Drug

Nombre de intervención: Emtricitabine

Tipo de intervención: Drug

Nombre de intervención: Stavudine

Tipo de intervención: Drug

Nombre de intervención: Didanosine

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Ubicación
Instalaciones:
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, District of Columbia, 20037, United States
Physicans Home Service | Washington, District of Columbia, 20037, United States
Gary Richmond MD | Fort Lauderdale, Florida, 33316, United States
Wohlfeiler, Piperator & King, MD, PA | Miami Beach, Florida, 33139, United States
South Miami Hosp | Miami, Florida, 33143, 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
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
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
Fanno Creek Clinic | Portland, Oregon, 97219, United States
Paragon Clinical Research | Cranston, Rhode Island, 02920, United States
Coastal Carolina Research Ctr | Mount 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
Ubicacion Paises

Argentina

Canada

Chile

Mexico

Puerto Rico

United States

Fecha de verificación

June 2006

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Información de diseño del estudio

Propósito primario: Treatment

Enmascaramiento: Double

Fuente: ClinicalTrials.gov