The purpose of this study is to look at the effectiveness of an anti-HIV drug combination that adds capravirine in patients who have failed their first drug combination treatment.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Capravirine  Drug: Nelfinavir mesylate	Phase II

Further Study Details: 

Expected Total Enrollment:  75

[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.] Both groups also receive nelfinavir mesylate and 2 NRTIs. All patients receive the same dose of nelfinavir mesylate. The NRTIs are selected at the investigator's discretion provided the patient has not previously received the chosen NRTIs. Patients have regular physical examinations. Blood samples are collected regularly and at 1 month post-treatment to determine plasma HIV RNA, pharmacokinetics, and CD4 and CD8 counts. Patients who complete 24 weeks of treatment will have the option to continue treatment for an additional 24 weeks or end participation.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Patients may be eligible for this trial if they:

• Are HIV-positive.
• Have a CD4 cell count more than 50/mm3.
• Are at least 18 years old.
• Have adequate blood, kidney, and liver functions.
• Are currently taking an anti-HIV drug combination of an NNRTI plus 1 or more NRTIs for more than 28 days and are failing that combination.

Exclusion Criteria

Patients will not be eligible for this trial if they:

• Have had any protease inhibitor or capravirine treatment.
• Have been given any drug that interferes with their immune system or with the study drugs within 28 days of study entry.
• Have had radiation therapy within 28 days of study entry.

Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85016,  United States
California
      Pacific Oaks Med Group, Beverly Hills,  California,  90211,  United States
      Harbor - UCLA Med Ctr, Torrance,  California,  90502,  United States
      Saint Francis Mem Hosp / HIV Care Unit, San Francisco,  California,  94109,  United States
      Kaiser Foundation Hospital, San Francisco,  California,  94118,  United States
      First Choice Medical, Palm Springs,  California,  92262,  United States
      Apogee Med Group, San Diego,  California,  92101,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Florida
      Treasure Coast Infectious Disease Consultants, Vero Beach,  Florida,  32960,  United States
      Therafirst Med Ctr, Fort Lauderdale,  Florida,  33308,  United States
      Bach and Godofsky, Bradenton,  Florida,  34205,  United States
      Hillsborough County Health Dept, Tampa,  Florida,  33602,  United States
      Community Health Care, Fort Lauderdale,  Florida,  33306,  United States
      South Shore Hosp, Miami,  Florida,  33139,  United States
      Orange County Health Dept, Orlando,  Florida,  32805,  United States
      Infectious Diseases Associates, Sarasota,  Florida,  34239,  United States
      Clin Research of West Florida, Clearwater,  Florida,  33765,  United States
      Immunity Care and Research Inc, Miami Beach,  Florida,  33139,  United States
      Polk County Health Dept, Winter Haven,  Florida,  33881,  United States
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States
      Braude Mermin Spivey MD PC, Atlanta,  Georgia,  30309,  United States
Massachusetts
      Fenway Community Health Ctr, Boston,  Massachusetts,  02115,  United States
      Massachusetts Gen Hosp, Boston,  Massachusetts,  02114,  United States
New Jersey
      Jersey Shore Med Ctr, Neptune,  New Jersey,  07753,  United States
      VAMC New Jersey Healthcare System, East Orange,  New Jersey,  07018,  United States
      Infectious Disease Assoc of Central Jersey, Somerville,  New Jersey,  08876,  United States
New York
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      North Shore Univ Hosp, Manhasset,  New York,  11030,  United States
      Liberty Medical, New York,  New York,  10014,  United States
      Biomedical Research Alliance of New York, Jamaica,  New York,  11432,  United States
Texas
      Univ TX Galveston Med Branch, Galveston,  Texas,  77555,  United States
      Central Texas Clinical Research, Austin,  Texas,  78705,  United States
Virginia
      Infectious Disease Physicians Inc, Annandale,  Virginia,  22203,  United States
Puerto Rico
      Clinical Research Puerto Rico Inc, San Juan,  009091711,  Puerto Rico

Study ID Numbers:  286D; AG1549-509
Record last reviewed:  March 2001
Last Updated:  October 13, 2004
Record first received:  March 15, 2000
ClinicalTrials.gov Identifier:  NCT00004985
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08