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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006208

  Show 63 Study Locations
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 August 01, 2014