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