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

June 23, 2005 updated by: Triangle Pharmaceuticals

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Triangle Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 298C
  • FTC-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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