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

Tracking Information
First Received Date ^ICMJE	September 11, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	August 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Double-Blind, Safety Study
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Efavirenz Drug: Emtricitabine Drug: Stavudine Drug: Didanosine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Canada, Chile, Mexico, Puerto Rico

Administrative Information
NCT ID ^ICMJE	NCT00006208
Responsible Party
Study ID Numbers ^ICMJE	298C, FTC-301
Study Sponsor ^ICMJE	Triangle Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	June 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP