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Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy



Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy

For Condition: HIV Infections
Status: Completed
Sponsor(s): Agouron Pharmaceuticals ,
Synopsis: 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.
Details: [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.
Eligibility:
Study Type:
  Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 75

Location and Contact Information:

Central Texas Clinical Research
Austin,  Texas,  78705
United States
 

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

Mount Sinai Med Ctr
New York City,  New York,  10029
United States
 

Braude Mermin Spivey MD PC
Atlanta,  Georgia,  30309
United States
 

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

Univ of Colorado Health Sciences Ctr
Denver,  Colorado,  80262
United States
 

Massachusetts Gen Hosp
Boston,  Massachusetts,  02114
United States
 

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

Infectious Disease Assoc of Central Jersey
Somerville,  New Jersey,  08876
United States
 

Fenway Community Health Ctr
Boston,  Massachusetts,  02115
United States
 

Bach and Godofsky
Bradenton,  Florida,  34205
United States
 

Polk County Health Dept
Winter Haven,  Florida,  33881
United States
 

Apogee Med Group
San Diego,  California,  92101
United States
 

Community Health Care
Ft. Lauderdale,  Florida,  33306
United States
 

Univ TX Galveston Med Branch
Galveston,  Texas,  77555
United States
 

Liberty Medical
New York City,  New York,  10014
United States
 

Infectious Diseases Associates
Sarasota,  Florida,  34239
United States
 

Jersey Shore Med Ctr
Neptune,  New Jersey,  07753
United States
 

South Shore Hosp
Miami,  Florida,  33139
United States
 

VAMC New Jersey Healthcare System
East Orange,  New Jersey,  07018
United States
 

Infectious Disease Physicians Inc
Annandale,  Virginia,  22203
United States
 

Clin Research of West Florida
Clearwater,  Florida,  33765
United States
 

First Choice Medical
Palm Springs,  California,  92262
United States
 

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

Phoenix Body Positive
Phoenix,  Arizona,  85016
United States
 

Therafirst Med Ctr
Ft. Lauderdale,  Florida,  33308
United States
 

Saint Francis Mem Hosp / HIV Care Unit
San Francisco,  California,  94109
United States
 

Biomedical Research Alliance of New York
Jamaica,  New York,  11432
United States
 

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

Hillsborough County Health Dept
Tampa,  Florida,  33602
United States
 

AIDS Research Consortium of Atlanta
Atlanta,  Georgia,  30308
United States
 

Orange County Health Dept
Orlando,  Florida,  32805
United States
 

Kaiser Foundation Hospital
San Francisco,  California,  94118
United States
 

Immunity Care and Research Inc
Miami,  Florida,  33139
United States
 


Additional Information:
Study ID Numbers:
  286D;  AG1549-509
Study Start Date: January 2000
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004985

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