A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00006208
Verified June 2006 by NIH AIDS Clinical Trials Information Service. Recruitment status was: Active, not recruiting
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 Start Date
Resource links provided by the National Library of Medicine
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, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.