Clinical trial NCT00006208: A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV-1
Didanosine
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Deoxycytidine
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Berkeley
country: United States
facility: East Bay AIDS Ctr
state: California
city: Concord
country: United States
facility: East Bay Clinical Trial Ctr
state: California
city: Long Beach
country: United States
facility: Mem Med Group Inc
state: California
city: Los Angeles
country: United States
facility: AIDS Healthcare Foundation
state: California
city: Newport Beach
country: United States
facility: Orange Coast Med Group
state: California
city: San Diego
country: United States
facility: St Lukes Medical Group
state: California
city: San Diego
country: United States
facility: Robert Smith Medical Group
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care
state: California
city: San Francisco
country: United States
facility: Davies Med Ctr
state: California
city: Boulder
country: United States
facility: Beacon Clinic / Boulder Community Hosp
state: Colorado
city: Denver
country: United States
facility: Univ of Colorado Health Ctr / Denver Gen Hosp
state: Colorado
city: Stamford
country: United States
facility: Blick Med Associates
state: Connecticut
city: Washington
country: United States
facility: George Washington Univ Med Ctr
state: District of Columbia
city: Washington
country: United States
facility: Physicans Home Service
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Gary Richmond MD
state: Florida
city: Miami Beach
country: United States
facility: Wohlfeiler, Piperator & King, MD, PA
state: Florida
city: Miami
country: United States
facility: South Miami Hosp
state: Florida
city: Palm Springs
country: United States
facility: Larry Bush
state: Florida
city: Safety Harbor
country: United States
facility: Health Positive
state: Florida
city: Sarasota
country: United States
facility: Infectious Diseases Associates
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Department
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Inst
state: Florida
city: Atlanta
country: United States
facility: Ingenix Kern McNeill Decatur
state: Georgia
city: Decatur
country: United States
facility: Infectious Disease Specialists of Atlanta
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Chicago
country: United States
facility: Northstar Med Clinic
state: Illinois
city: New Orleans
country: United States
facility: Tulane Univ Med Ctr / Infectious Diseases Sect
state: Louisiana
city: Baltimore
country: United States
facility: Institute of Human Virology
state: Maryland
city: Boston
country: United States
facility: New England Med Ctr
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health Ctr
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hosp / Clinic 42
state: Minnesota
city: Somers Point
country: United States
facility: South Jersey Infectious Diseases Inc
state: New Jersey
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Buffalo
country: United States
facility: Erie County Med Ctr
state: New York
city: Manhasset
country: United States
facility: North Shore Univ Hosp / Div of Infectious Diseases
state: New York
city: New York
country: United States
facility: Dr Lawrence Fontana
state: New York
city: New York
country: United States
facility: Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
state: New York
city: New York
country: United States
facility: Howard Grossman
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Portland
country: United States
facility: Fanno Creek Clinic
state: Oregon
city: Cranston
country: United States
facility: Paragon Clinical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Ctr
state: South Carolina
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Nelson Tebedo Health Resource Ctr
state: Texas
city: Dallas
country: United States
facility: Amelia Ct Clinic
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Houston
country: United States
facility: Houston Clinical Research Network
state: Texas
city: Houston
country: United States
facility: Diversified Med Practices, PA
state: Texas
city: Irving
country: United States
facility: Walter Gaman
state: Texas
city: Seattle
country: United States
facility: Swedish Med Ctr / Dr Peter Shalit
state: Washington
city: Buenos Aires
country: Argentina
facility: FUNCEI
city: Buenos Aires
country: Argentina
facility: Fundacion HUES
city: Buenos Aires
country: Argentina
facility: Hospital de Agudos JM Ramos Mejia
city: Buenos Aires
country: Argentina
facility: Hospital Muniz
city: Mar del Plata
country: Argentina
facility: Hospital Interzonal Gen de Agudos Oscar Alende
city: Vancouver
country: Canada
facility: Viridae Clinical Sciences / University of British Columbia
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster Univ Med Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Gen Hosp
state: Quebec
city: Ste Foy
country: Canada
facility: Centre De Recherche En Infectiologie
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arriaran
city: Mexico City
country: Mexico
facility: Instituto Nacional de la Nutricion
city: San Juan
country: Puerto Rico
facility: San Juan Veterans Administration Med Ctr
Study officials:
References: