A Comparison of Two Drug Combinations Used in HIV-Infected Patients Who Never Have Taken Anti-HIV Drugs

Condition(s) targeted: HIV Infections

Intervention: Tenofovir disoproxil fumarate (Drug); Efavirenz (Drug); Lamivudine (Drug); Stavudine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Gilead Sciences

The purpose of this study is to compare the effectiveness of treatment with tenofovir DF (TDF) plus lamivudine (3TC) plus efavirenz (EFV) with that of stavudine (d4T) plus 3TC plus EFV in HIV-infected patients who previously have not used anti-HIV drugs.

Official title: A Phase 3, Randomized, Double-Blind, Multicenter Study of the Treatment of Antiretroviral-Naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz Versus Stavudine, Lamivudine, and Efavirenz

Study design: Treatment, Parallel Assignment

Detailed description: Patients will be stratified on the basis of HIV-1 RNA levels (greater than 100,000 copies/ml or less than or equal to 100,000 copies/ml) and CD4 count (less than 200 cells/mm3 or greater than or equal to 200 cells/mm3). Treatment-naive patients with HIV-1 RNA levels greater than 5,000 copies/ml will be randomized 1: 1 to 1 of 2 treatment arms:

Group 1: TDF + d4T placebo + 3TC + EFV Group 2: TDF placebo + d4T + 3TC + EFV TDF/placebo and d4T/placebo will be administered in a blinded fashion. 3TC, EFV, and nevirapine (administered in the event of EFV-associated CNS toxicity) will be administered in open-label fashion. Patients will be monitored for safety using periodic physical examinations, serial laboratory tests, and bone densitometry tests. Additionally, changes in plasma HIV-1 RNA levels and CD4 cell counts will be monitored to assess antiviral efficacy. At the end of Week 48, patients without dose-limiting toxicity will have the option to roll over into open-label extended dosing until tenofovir DF is commercially available or Gilead Sciences terminates the study. Only open-label tenofovir DF will be provided beyond Week 48.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

Patients may be eligible for this study if they:

- Are 18 to 65 years old.

- Are HIV-1 positive.

- Have HIV-1 RNA levels greater than 5,000 copies/ml within 28 days of screening visit.

- Agree to use effective methods of birth control during study and for 30 days after

study ends.

Exclusion Criteria

Patients will not be eligible for this study if they:

- Are unable to take medications by mouth.

- Have chronic nausea or vomiting.

- Have cancer, other than skin cancer.

- Have had active, serious infections requiring antibiotic shots within 15 days prior to

screening.

- Are taking probenecid, systemic corticosteroids, interleukin-2 (IL-2), experimental

drugs (unless approved by Gilead Sciences), drugs that are harmful to the kidneys, or drugs that interact with efavirenz.

- Are receiving chemotherapy.

- Have been diagnosed with an AIDS-defining condition.

- Have had significant kidney or bone disease.

- Have ever taken certain anti-HIV drugs.

- Have had chemotherapy or immunizations within 30 days of beginning of study.

- Are pregnant or breast-feeding.

- Have a condition which may affect the ability to participate in this study, such as

alcohol or substance abuse.

- Have received, or expect to receive, treatment for Kaposi's sarcoma.

Inst Dom De Estudios Virologicos, Santa Domingo, Dominican Republic

San Juan AIDS Program, Santurce 00908, Puerto Rico

Hosp Regional de Ponce, Ponce 00731, Puerto Rico

Clinical Research Puerto Rico Inc, San Juan 009091711, Puerto Rico

Phoenix Body Positive, Phoenix, Arizona 85006, United States

San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States

Harbor - UCLA Med Ctr, Torrance, California 90502, United States

Pacific Oaks Med Group, Beverly Hills, California 90211, United States

Tower Infectious Disease Med Ctr, Los Angeles, California 90048, United States

Ocean View Internal Medicine, Long Beach, California 90803, United States

Univ of California, San Diego, San Diego, California 92103, United States

Living Hope Clinical Trials, Long Beach, California 90813, United States

George Washington Univ Med Ctr, Washington, District of Columbia 20037, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

Steinhart Medical Associates, Miami, Florida 33133, United States

Univ of Miami / Jackson Memorial Hosp, Miami, Florida 33136, United States

Univ of Florida HSC, Jacksonville, Florida 322096561, United States

Treasure Coast Infectious Disease Consultants, Vero Beach, Florida 32960, United States

Hillsborough County Health Dept, Tampa, Florida 33602, United States

South Shore Hosp, Miami, Florida 33139, United States

Palm Beach County Health Department, Riviera Beach, Florida 33404, United States

North Broward Hosp, Fort Lauderdale, Florida 33311, United States

Infectious Disease Research Inst, Tampa, Florida 33614, United States

IDC Research Initiative, Altamonte Springs, Florida 32701, United States

Mercer University School of Medicine, Macon, Georgia 31201, United States

Chicago Ctr for Clinical Research, Chicago, Illinois 60610, United States

Northstar Med Clinic, Chicago, Illinois 60657, United States

Indiana Univ Hosp, Indianapolis, Indiana 462025250, United States

Chandler Med Ctr, Lexington, Kentucky 405360084, United States

Johns Hopkins Univ School of Medicine, Baltimore, Maryland 212870003, United States

Boston Med Ctr, Boston, Massachusetts 02118, United States

CRI New England, Brookline, Massachusetts 02445, United States

CRI - Springfield, Springfield, Massachusetts 01107, United States

Family Health Care Ctr at SSTAR, Fall River, Massachusetts 02720, United States

Kansas City Free Health Clinic, Kansas City, Missouri 64111, United States

North Shore Univ Hosp, Manhasset, New York 11030, United States

Rockefeller Univ, New York, New York 10021, United States

St Vincents Hosp / Clinical Research Program, New York, New York 10011, United States

Carolinas Med Ctr, Charlotte, North Carolina 28203, United States

Univ of North Carolina / SOCA, Chapel Hill, North Carolina 275997030, United States

Wake Forest Univ School of Medicine, Winston Salem, North Carolina 27157, United States

Nalle Clinic / Clinical Research Dept, Charlotte, North Carolina 28207, United States

Jemsek Clinic, Huntersville, North Carolina 28078, United States

Univ Hospital, Oklahoma City, Oklahoma 73104, United States

Miriam Hosp, Providence, Rhode Island 02906, United States

Julio Arroyo, West Columbia, South Carolina 29169, United States

Coastal Carolina Research Ctr, Mount Pleasant, South Carolina 29464, United States

N Texas Ctr for AIDS & Clin Rsch, Dallas, Texas 75219, United States

Univ of Texas Med Branch, Galveston, Texas 775550835, United States

Univ of Texas / Thomas Street Clinic, Houston, Texas 77030, United States

Gary Brewton, Houston, Texas 77098, United States

Southwest Infectious Diseases Associates, Dallas, Texas 75246, United States

Hampton Roads Med Specialists, Hampton, Virginia 23666, United States

Virginia Commonwealth Univ, Richmond, Virginia 23298, United States

Infections Ltd / Physicians Med Ctr, Tacoma, Washington 98405, United States

Related publications:

McGowan I, Cheng A, Coleman S, Johnson A, Genant H. Assessment of bone mineral density (BMD) in HIV-infected antiretroviral-therapy-naive patients. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 628)

Starting date: March 2000
Last updated: June 23, 2005