search
Back to results

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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Efavirenz
Emtricitabine
Stavudine
Didanosine
Sponsored by
Triangle Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Didanosine, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Deoxycytidine, efavirenz

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ of Alabama at Birmingham
  • East Bay AIDS Ctr
  • East Bay Clinical Trial Ctr
  • Mem Med Group Inc
  • AIDS Healthcare Foundation
  • Orange Coast Med Group
  • St Lukes Medical Group
  • Robert Smith Medical Group
  • Saint Francis Mem Hosp / HIV Care
  • Davies Med Ctr
  • Beacon Clinic / Boulder Community Hosp
  • Univ of Colorado Health Ctr / Denver Gen Hosp
  • Blick Med Associates
  • George Washington Univ Med Ctr
  • Physicans Home Service
  • Gary Richmond MD
  • Wohlfeiler, Piperator & King, MD, PA
  • South Miami Hosp
  • Larry Bush
  • Health Positive
  • Infectious Diseases Associates
  • Hillsborough County Health Department
  • Infectious Disease Research Inst
  • Ingenix Kern McNeill Decatur
  • Infectious Disease Specialists of Atlanta
  • Harbin Clinic
  • Northstar Med Clinic
  • Tulane Univ Med Ctr / Infectious Diseases Sect
  • Institute of Human Virology
  • New England Med Ctr
  • Fenway Community Health Ctr
  • Abbott-Northwestern Hosp / Clinic 42
  • South Jersey Infectious Diseases Inc
  • Albert Einstein College of Medicine
  • Erie County Med Ctr
  • North Shore Univ Hosp / Div of Infectious Diseases
  • Dr Lawrence Fontana
  • Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
  • Howard Grossman
  • Mount Sinai School of Medicine
  • Fanno Creek Clinic
  • Paragon Clinical Research
  • Coastal Carolina Research Ctr
  • Central Texas Clinical Research
  • Nelson Tebedo Health Resource Ctr
  • Amelia Ct Clinic
  • Univ TX Galveston Med Branch
  • Houston Clinical Research Network
  • Diversified Med Practices, PA
  • Walter Gaman
  • Swedish Med Ctr / Dr Peter Shalit
  • FUNCEI
  • Fundacion HUES
  • Hospital de Agudos JM Ramos Mejia
  • Hospital Muniz
  • Hospital Interzonal Gen de Agudos Oscar Alende
  • Viridae Clinical Sciences / University of British Columbia
  • McMaster Univ Med Centre
  • Montreal Gen Hosp
  • Centre De Recherche En Infectiologie
  • Fundacion Arriaran
  • Instituto Nacional de la Nutricion
  • San Juan Veterans Administration Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2000
Last Updated
June 23, 2005
Sponsor
Triangle Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00006208
Brief Title
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

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Triangle Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Didanosine, Drug Therapy, Combination, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Deoxycytidine, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Emtricitabine
Intervention Type
Drug
Intervention Name(s)
Stavudine
Intervention Type
Drug
Intervention Name(s)
Didanosine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
352942050
Country
United States
Facility Name
East Bay AIDS Ctr
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
East Bay Clinical Trial Ctr
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Mem Med Group Inc
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Orange Coast Med Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
St Lukes Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Robert Smith Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Saint Francis Mem Hosp / HIV Care
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Davies Med Ctr
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Beacon Clinic / Boulder Community Hosp
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Univ of Colorado Health Ctr / Denver Gen Hosp
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Blick Med Associates
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06901
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Physicans Home Service
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Gary Richmond MD
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Wohlfeiler, Piperator & King, MD, PA
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
South Miami Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Larry Bush
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Health Positive
City
Safety Harbor
State/Province
Florida
ZIP/Postal Code
34695
Country
United States
Facility Name
Infectious Diseases Associates
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Hillsborough County Health Department
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Infectious Disease Research Inst
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Ingenix Kern McNeill Decatur
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Harbin Clinic
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Northstar Med Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Tulane Univ Med Ctr / Infectious Diseases Sect
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Institute of Human Virology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
New England Med Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Fenway Community Health Ctr
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Abbott-Northwestern Hosp / Clinic 42
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
South Jersey Infectious Diseases Inc
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Erie County Med Ctr
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
North Shore Univ Hosp / Div of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Dr Lawrence Fontana
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Liberty Medical / Cabrini Hospital / Dept of Infec Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Howard Grossman
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Fanno Creek Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Paragon Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Coastal Carolina Research Ctr
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Nelson Tebedo Health Resource Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Amelia Ct Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Clinical Research Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Diversified Med Practices, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
Walter Gaman
City
Irving
State/Province
Texas
ZIP/Postal Code
75038
Country
United States
Facility Name
Swedish Med Ctr / Dr Peter Shalit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
FUNCEI
City
Buenos Aires
Country
Argentina
Facility Name
Fundacion HUES
City
Buenos Aires
Country
Argentina
Facility Name
Hospital de Agudos JM Ramos Mejia
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Muniz
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Interzonal Gen de Agudos Oscar Alende
City
Mar del Plata
Country
Argentina
Facility Name
Viridae Clinical Sciences / University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
McMaster Univ Med Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Montreal Gen Hosp
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre De Recherche En Infectiologie
City
Ste Foy
State/Province
Quebec
Country
Canada
Facility Name
Fundacion Arriaran
City
Santiago
Country
Chile
Facility Name
Instituto Nacional de la Nutricion
City
Mexico City
Country
Mexico
Facility Name
San Juan Veterans Administration Med Ctr
City
San Juan
ZIP/Postal Code
009275800
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs