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

This study is ongoing, but not recruiting participants.

Sponsored by: Triangle Pharmaceuticals
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00006208
  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 III

MedlinePlus related topics:   AIDS    AIDS Medicines   

Drug Information available for:   Didanosine    Stavudine    Efavirenz    Deoxycytidine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Safety Study
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

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

Show 63 study locations  Show 63 Study Locations

Sponsors and Collaborators
Triangle Pharmaceuticals
  More Information


Study ID Numbers:   298C, FTC-301
First Received:   September 11, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00006208
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

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Stavudine
Didanosine
Emtricitabine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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