The purpose of this study is to look at the effects of different anti-HIV drug combinations
on body fat changes in HIV-positive patients who have never received anti-HIV therapy
before.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria
Patients may be eligible for this study if they:
- Are at least 18 years old.
- Are HIV-positive.
- Have a CD4 count greater than 50 cells/mm3.
- Have a viral load greater than 1,000 copies/ml but less than 200,000 copies/ml.
- Have never received anti-HIV medications before. (However, less than 1 week of therapy
with lamivudine or a protease inhibitor and less than 4 weeks of therapy with other
nucleoside reverse transcriptase inhibitors [NRTIs] is allowed. No therapy with
nonnucleoside reverse transcriptase inhibitors [NNRTIs] is allowed.)
- Cannot bear children or agree to use effective methods of birth control during the
study. Hormonal methods of birth control (such as birth control pills) are not
considered effective for this study.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have an active AIDS-defining opportunistic infection or disease that, in the doctor's
opinion, would make them unable to participate.
- Are unable, in the opinion of the doctor, to follow the dosing schedule and follow-up
visit schedule.
- Have a substance abuse problem that would interfere with taking the medications
correctly or attending the clinic visits.
- Are enrolled in another study.
- Cannot take medications by mouth or absorb drugs.
- Have hepatitis.
- Have a serious medical condition such as diabetes, congestive heart failure, or other
heart disease.
- Need chemotherapy or radiation therapy (except for local treatment of Kaposi's
sarcoma).
- Are taking certain medications.
- Are pregnant or breast-feeding.
Univ of Alabama at Birmingham, Birmingham, Alabama 352942050, United States
Arizona Clinical Research Ctr Inc, Tucson, Arizona 85712, United States
Highland Gen Hosp / San Francisco Gen Hosp, Oakland, California 946021018, United States
San Francisco Gen Hosp, San Francisco, California 94110, United States
UCLA Care Ctr, Los Angeles, California 90095, United States
AIDS Healthcare Foundation, Los Angeles, California 900276069, United States
Maxine Liggins, Los Angeles, California 90042, United States
Good Samaritan Hosp, Los Angeles, California 90004, United States
THE Clinic, Los Angeles, California 90008, United States
Longbeach Memorial Med Ctr, Longbeach, California 90806, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Univ of Miami School of Medicine, Miami, Florida 33136, United States
Children's Diagnostic Treatment Ctr, Fort Lauderdale, Florida 33301, United States
Infectious Disease Research Institute, Tampa, Florida 33614, United States
Community Health Care, Fort Lauderdale, Florida 33306, United States
South Shore Hosp, Miami, Florida 33139, United States
Immunity Care and Research Inc, Plantation, Florida 33324, United States
Comprehensive Care Center, Fort Lauderdale, Florida 33316, United States
Daniel Seekins, Tampa, Florida 33607, United States
Orange County Health Dept, Orlando, Florida 32805, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
Ponce de Leon Ctr, Atlanta, Georgia 30308, United States
Philip Brachman, Atlanta, Georgia 30309, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois 60612, United States
Cook County Hosp, Chicago, Illinois 60614, United States
HIV Outpatient Clinics / LA State Univ Med Ctr, New Orleans, Louisiana 70112, United States
Beth Israel Deaconess Med Ctr, Boston, Massachusetts 02215, United States
Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri 64108, United States
South Jersey Infectious Diseases Inc, Somers Point, New Jersey 08244, United States
Carolinas Med Ctr, Charlotte, North Carolina 28232, United States
WNC Community Health Services, Asheville, North Carolina 28806, United States
Summa Health System, Akron, Ohio 44304, United States
MCP Hahnemann Univ Hosp, Philadelphia, Pennsylvania 19102, United States
Miriam Hosp, Providence, Rhode Island 02906, United States
Univ of Texas Southwestern Med Ctr, Dallas, Texas 75235, United States
Univ TX San Antonio Health Science Ctr, San Antonio, Texas 782847881, United States
Thomas Street Clinic, Houston, Texas 77009, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States