A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection
- Conditions
- HIV Infections
- Registration Number
- NCT00000919
- Brief Summary
The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV).
Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.
- Detailed Description
Highly active antiretroviral therapy, though effective in the suppression of HIV proliferation, is often complicated by difficulties with adherence and drug toxicity. Various combinations of highly active antiretroviral therapy exist; all have proved efficacious in related trials. The question addressed in this trial is which combination of antiretroviral "cocktails" provides the single greatest advantage in preventing the spread of HIV in the body. In effect, which therapy provides the greatest benefit with the fewest complications.
Step 1: Patients are randomized to 1 of 6 arms:
Arm A: didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV) placebo.
Arm B: ddI, d4T, EFV placebo, and NFV. Arm C: lamivudine (3TC)/zidovudine (ZDV), EFV, and NFV placebo. Arm D: 3TC/ZDV, EFV placebo, and NFV. Arm E: ddI, d4T, EFV, and NFV. Arm F: 3TC/ZDV, EFV, and NFV. Patients with virologic failure on 2 successive measurements or study-drug intolerance discontinue their randomized study therapy and proceed to Step 2. \[AS PER AMENDMENT 7/5/00: Patients must switch regimens as soon as possible after confirmation of virologic failure to prevent development of drug resistance.\]
Step 2:
Arm A: Patients receive treatment as in Arm D of Step 1. Arm B: Patients receive treatment as in Arm C of Step 1. Arm C: Patients receive treatment as in Arm B of Step 1. Arm D: Patients receive treatment as in Arm A of Step 1. Arms A, B, C, and D: Patients who fail Step 2 treatment proceed to Step 3. Arms E and F: Patients with virologic failure on Step 1 proceed immediately to Step 3.
Step 3 (salvage therapy):
Arm A, B, C, and D: Patients receive indinavir (IDV), amprenavir (APV), ddI, and hydroxyurea (HU).
\[AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 1, 2, 3, 4, 5, or 6. Regimen 1 consists of IDV, ritonavir (RTV), ddI, and HU. Regimen 2 consists of APV, RTV, ddI, and HU. Regimen 3 consists of IDV, RTV, abacavir (ABC), and 3TC/ZDV. Regimen 4 consists of APV, RTV, ABC, and 3TC/ZDV. Regimen 5 consists of IDV, RTV, ABC, d4T, and 3TC. Regimen 6 consists of APV, RTV, ABC, d4T, and 3TC.\] Arm E: Patients receive IDV, APV, and 3TC/ZDV. \[AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 7 or 8. Regimen 7 consists of IDV, RTV, and 3TC/ZDV. Regimen 8 consists of APV, RTV, and 3TC/ZDV.\] Arm F: Patients receive IDV, APV, ddI, and d4T. \[AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 9 or 10. Regimen 9 consists of IDV, RTV, ddI, and d4T. Regimen 10 consists of APV, RTV, ddI, and d4T.\] \[AS PER AMENDMENT 7/5/00: Patients already enrolled in Step 3 before site registration to Version 4.0 of this protocol have the option of receiving 1 of the appropriate new Step 3 regimens as outlined above or staying on their originally assigned Step 3 therapy.\] \[AS PER AMENDMENT 3/21/01: If virologic failure on Step 1 or 2 is confirmed, then HIV-1 RNA genotype resistance testing (in real-time, if possible) is performed. Patients receive 1 of the Step 3 drug regimens based on the results of the resistance testing.\] Patients may co-enroll in metabolic, pharmacologic, immunologic, or adherence substudies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (80)
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Marin County Specialty Clinic
🇺🇸San Rafael, California, United States
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr
🇺🇸Atlanta, Georgia, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp of Indiana / Life Care Clinic
🇺🇸Indianapolis, Indiana, United States
State of MD Div of Corrections / Johns Hopkins Univ Hosp
🇺🇸Baltimore, Maryland, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Kentucky Lexington
🇺🇸Cincinnati, Ohio, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Archispedale S Maria Nuova
🇮🇹Reggio Emilia, Italy
Akron City Hospital
🇺🇸Akron, Ohio, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
MetroHealth Med Ctr
🇺🇸Cleveland, Ohio, United States
Philadelphia Veterans Administration Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Puerto Rico
🇵🇷San Juan, Puerto Rico
Azienda USL di Piacenza
Francesco Leoncini
Azienda Ospedaliera Umberto I
🇮🇹Ancona, Italy
Ospedale S Orsola
🇮🇹Bologna, Italy
Spedali Civili - Carosi
🇮🇹Brescia, Italy
Spedali Civili Cadeo
🇮🇹Brescia, Italy
Archispedale S Anna
🇮🇹Ferrara, Italy
Universita di Genova
🇮🇹Genova, Italy
Ospedale Luigi Cacco Moroni
🇮🇹Milano, Italy
Ospedale Luigi Sacco Cargnel
🇮🇹Milano, Italy
Azienda Ospedaliera di Parma
🇮🇹Parma, Italy
IRCCS Policlinico S Matteo Filice
🇮🇹Pavia, Italy
IRCCS Policlinico S Matteo Minoli
🇮🇹Pavia, Italy
Ospedale Civile Maggiore
🇮🇹Verona, Italy
Universita di Roma - Delia
🇮🇹Roma, Italy
Univ of Pittsburgh Med Ctr
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of Texas Galveston
🇺🇸Galveston, Texas, United States
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Georgetown Univ Hosp
🇺🇸Washington, District of Columbia, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Howard Univ
🇺🇸Washington, District of Columbia, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Univ of Iowa Hosp and Clinic
🇺🇸Iowa City, Iowa, United States
Tulane Med Ctr Hosp
🇺🇸New Orleans, Louisiana, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
🇺🇸St Louis, Missouri, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Manhattan Veterans Administration / New York Univ Med Ctr
🇺🇸New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
🇺🇸Rochester, New York, United States
Chelsea Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States