A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006208
• Other study ID #: 298C
• Secondary ID: FTC-301
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2000
• Last updated: June 23, 2005
• Start date: August 2000

Study information

• Verified date: June 2006
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Emtricitabine

• Stavudine

• Didanosine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Triangle Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Mexico,  Puerto Rico,