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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by NIH AIDS Clinical Trials Information Service.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00006208
First received: September 11, 2000
Last updated: June 23, 2005
Last verified: June 2006
  Purpose

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 Intervention Phase
HIV Infections
Drug: Efavirenz
Drug: Emtricitabine
Drug: Stavudine
Drug: Didanosine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date: August 2000
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006208

  Hide Study Locations
Locations
United States, Alabama
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 352942050
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
East Bay Clinical Trial Ctr
Concord, California, United States, 94520
Mem Med Group Inc
Long Beach, California, United States, 90806
AIDS Healthcare Foundation
Los Angeles, California, United States, 90027
Orange Coast Med Group
Newport Beach, California, United States, 92663
St Lukes Medical Group
San Diego, California, United States, 92101
Robert Smith Medical Group
San Diego, California, United States, 92103
Davies Med Ctr
San Francisco, California, United States, 94114
Saint Francis Mem Hosp / HIV Care
San Francisco, California, United States, 94109
United States, Colorado
Beacon Clinic / Boulder Community Hosp
Boulder, Colorado, United States, 80304
Univ of Colorado Health Ctr / Denver Gen Hosp
Denver, Colorado, United States, 80262
United States, Connecticut
Blick Med Associates
Stamford, Connecticut, United States, 06901
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Physicans Home Service
Washington, District of Columbia, United States, 20037
United States, Florida
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
South Miami Hosp
Miami, Florida, United States, 33143
Wohlfeiler, Piperator & King, MD, PA
Miami Beach, Florida, United States, 33139
Larry Bush
Palm Springs, Florida, United States, 33461
Health Positive
Safety Harbor, Florida, United States, 34695
Infectious Diseases Associates
Sarasota, Florida, United States, 34239
Hillsborough County Health Department
Tampa, Florida, United States, 33602
Infectious Disease Research Inst
Tampa, Florida, United States, 33614
United States, Georgia
Ingenix Kern McNeill Decatur
Atlanta, Georgia, United States, 30309
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
Harbin Clinic
Rome, Georgia, United States, 30165
United States, Illinois
Northstar Med Clinic
Chicago, Illinois, United States, 60657
United States, Louisiana
Tulane Univ Med Ctr / Infectious Diseases Sect
New Orleans, Louisiana, United States, 70112
United States, Maryland
Institute of Human Virology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
New England Med Ctr
Boston, Massachusetts, United States, 02111
Fenway Community Health Ctr
Boston, Massachusetts, United States, 02115
United States, Minnesota
Abbott-Northwestern Hosp / Clinic 42
Minneapolis, Minnesota, United States, 55404
United States, New Jersey
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, United States, 08244
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Erie County Med Ctr
Buffalo, New York, United States, 14215
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, United States, 11030
Dr Lawrence Fontana
New York, New York, United States, 10003
Howard Grossman
New York, New York, United States, 10011
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Oregon
Fanno Creek Clinic
Portland, Oregon, United States, 97219
United States, Rhode Island
Paragon Clinical Research
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Coastal Carolina Research Ctr
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Nelson Tebedo Health Resource Ctr
Dallas, Texas, United States, 75219
Amelia Ct Clinic
Dallas, Texas, United States, 75235
Univ TX Galveston Med Branch
Galveston, Texas, United States, 77555
Houston Clinical Research Network
Houston, Texas, United States, 77006
Diversified Med Practices, PA
Houston, Texas, United States, 77027
Walter Gaman
Irving, Texas, United States, 75038
United States, Washington
Swedish Med Ctr / Dr Peter Shalit
Seattle, Washington, United States, 98104
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
Montreal Gen Hosp
Montreal, Quebec, Canada
Centre De Recherche En Infectiologie
Ste Foy, 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, Puerto Rico, 009275800
Sponsors and Collaborators
Triangle Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006208     History of Changes
Other Study ID Numbers: 298C, FTC-301
Study First Received: September 11, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Didanosine
Drug Therapy, Combination
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Deoxycytidine
efavirenz

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Stavudine
Reverse Transcriptase Inhibitors
Efavirenz
Anti-HIV Agents
Emtricitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014