The purpose of this study is to better understand the relationship between age and HIV disease progression. This study will explore the possible relationship between age and HIV disease progression. Older age is an important risk factor for faster disease development, but older people may respond better to combination drug therapy. This relationship needs to be understood better.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Lopinavir/Ritonavir  Drug: Emtricitabine  Drug: Stavudine	Phase II

Further Study Details: 

Expected Total Enrollment:  90

Older age is an important risk factor for accelerated HIV-disease progression. However, the virologic response to highly active antiretroviral therapy (HAART) may be superior in older persons. A better understanding of the immunologic, virologic, and behavioral mechanisms that underlie these age-related differences may help to elucidate critical immune responses that are necessary to control the progression of HIV-disease.

Patients are grouped according to age. Group A consists of patients between the ages of 13 and 30 years. Group B consists of patients age 45 years or older. All patients receive open-label lopinavir/ritonavir (LPV/RTV) plus emtricitabine (FTC) plus stavudine (d4T) for 96 [AS PER AMENDMENT 06/04/02: 192] weeks. Study visits occur at pre-entry, entry, and Weeks 4, 8, 12, 16, and 24 then every 12 weeks thereafter through Week 96 [AS PER AMENDMENT 06/04/02: Week 192]. Clinical assessments, safety laboratory tests, CD4 cell count monitoring, lymphocyte phenotyping, and HIV-1 RNA determinations are performed routinely. Blood samples are stored for further immunology and virology studies. Patients may volunteer to participate in virology substudy A5020s and either immunology substudy A5016s or A5017s [AS PER AMENDMENT 06/04/02: Substudy A5017s has been eliminated.]

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are HIV-positive.
• Are between 13 and 30 years old (need consent of parent or guardian if under 18), or are more than 44 years of age.
• Have a viral load of more than 2000 copies/ml within 60 days of study entry.
• Have a CD4 cell count of less than 600 cells/mm3 within 60 days of study entry. (This reflects a change in the CD4 cell count requirement.)
• Agree to use effective methods of birth control (such as condoms) during and for 12 weeks after the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Are pregnant or breast-feeding.
• Have an AIDS-related cancer (except Kaposi's sarcoma) requiring chemotherapy.
• Have hepatitis within 30 days of study entry.
• Have diarrhea (more than 3 liquid stools/day for at least 14 days) within 30 days of study entry.
• Are receiving chemotherapy or radiation treatment.
• Have taken antiretroviral drugs for more than 14 days.
• Have received an HIV vaccine within 30 days of study.
• Have a serious illness or infection within 14 days of the study.
• Have other serious conditions that might interfere with study participation.
• Have taken or plan to take certain other drugs that might affect the study results.

California
      San Francisco Gen Hosp, San Francisco,  California,  941102859,  United States
      Stanford Univ Med Ctr, Stanford,  California,  943055107,  United States
      Univ of Southern California / LA County USC Med Ctr, Los Angeles,  California,  900331079,  United States
      San Mateo AIDS Program / Stanford Univ, Stanford,  California,  943055107,  United States
      Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium, San Jose,  California,  951282699,  United States
      Marin County Specialty Clinic, San Rafael,  California,  94903,  United States
      Willow Clinic, Menlo Park,  California,  94025,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
      Denver Dept of Health and Hosps, Denver,  Colorado,  80262,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  331361013,  United States
Hawaii
      Queens Med Ctr, Honolulu,  Hawaii,  96816,  United States
      Univ of Hawaii, Honolulu,  Hawaii,  96816,  United States
Illinois
      Northwestern Univ Med School, Chicago,  Illinois,  60611,  United States
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  462025250,  United States
      Methodist Hosp of Indiana / Life Care Clinic, Indianapolis,  Indiana,  46202,  United States
      Wishard Hosp, Indianapolis,  Indiana,  46202,  United States
Maryland
      Johns Hopkins Hosp, Baltimore,  Maryland,  21287,  United States
      State of MD Div of Corrections / Johns Hopkins Univ Hosp, Baltimore,  Maryland,  212052196,  United States
Massachusetts
      Harvard (Massachusetts Gen Hosp), Boston,  Massachusetts,  02114,  United States
      Boston Med Ctr, Boston,  Massachusetts,  02118,  United States
      Brigham and Women's Hosp, Boston,  Massachusetts,  02215,  United States
Minnesota
      Univ of Minnesota, Minneapolis,  Minnesota,  55455,  United States
New York
      Univ of Rochester Medical Center, Rochester,  New York,  14642,  United States
      Bellevue Hosp / New York Univ Med Ctr, New York,  New York,  10016,  United States
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Beth Israel Med Ctr, New York,  New York,  10003,  United States
      Community Health Network Inc, Rochester,  New York,  14642,  United States
North Carolina
      Univ of North Carolina, Chapel Hill,  North Carolina,  275997215,  United States
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States
      Carolinas Med Ctr, Charlotte,  North Carolina,  28232,  United States
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States
      MetroHealth Med Ctr, Cleveland,  Ohio,  441091998,  United States
Pennsylvania
      Univ of Pennsylvania at Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States
      Philadelphia Veterans Administration Med Ctr, Philadelphia,  Pennsylvania,  19104,  United States
Rhode Island
      Miriam Hosp / Brown Univ, Providence,  Rhode Island,  02906,  United States
South Carolina
      Julio Arroyo, West Columbia,  South Carolina,  29169,  United States
Texas
      Univ of Texas Galveston, Galveston,  Texas,  775550435,  United States
      Univ of Texas, Southwestern Med Ctr of Dallas, Dallas,  Texas,  75390,  United States
Washington
      Univ of Washington, Seattle,  Washington,  98104,  United States
Puerto Rico
      Univ of Puerto Rico, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

Robert Kalayjian,  Study Chair
Michael Lederman,  Study Chair
Richard Pollard,  Study Chair

Study ID Numbers:  ACTG A5015; Substudy ACTG A5016s; Substudy ACTG A5020s; AACTG A5015
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  August 7, 2000
ClinicalTrials.gov Identifier:  NCT00006144
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08