Clinical trial NCT00004985: Combination Treatment Using Capravirine (AG1549), Nelfinavir, and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Patients Who Failed Initial Combination Therapy
Official title: A Phase II, Single-Blind, Randomized, Placebo-Controlled Study of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV-Infected Subjects Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
HIV Protease Inhibitors
RNA, Viral
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Nelfinavir
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: \[Note: As of 2/28/2001, due to toxicity studies and concern for safety, changes in the methodology were implemented and patients need to sign new informed consents. The study is unblinded. Group 1 receives AG1549; Group 2 receives an AG1549 placebo. Patients who are taking capravirine and who currently have viral loads below 400 copies/ml may continue to take capravirine at 1400 mg twice daily. Capravirine will be discontinued in patients with viral loads greater than 400 copies/ml at their last visit and they will be switched to new therapies or continue with their background therapies as deemed appropriate by the investigators.\] 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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Body Positive
state: Arizona
city: Beverly Hills
country: United States
facility: Pacific Oaks Med Group
state: California
city: Palm Springs
country: United States
facility: First Choice Medical
state: California
city: San Diego
country: United States
facility: Apogee Med Group
state: California
city: San Francisco
country: United States
facility: Saint Francis Mem Hosp / HIV Care Unit
state: California
city: San Francisco
country: United States
facility: Kaiser Foundation Hospital
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Bradenton
country: United States
facility: Bach and Godofsky
state: Florida
city: Clearwater
country: United States
facility: Clin Research of West Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Community Health Care
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Med Ctr
state: Florida
city: Miami Beach
country: United States
facility: Immunity Care and Research Inc
state: Florida
city: Miami
country: United States
facility: South Shore Hosp
state: Florida
city: Orlando
country: United States
facility: Orange County Health Dept
state: Florida
city: Sarasota
country: United States
facility: Infectious Diseases Associates
state: Florida
city: Tampa
country: United States
facility: Hillsborough County Health Dept
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Winter Haven
country: United States
facility: Polk County Health Dept
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Braude Mermin Spivey MD PC
state: Georgia
city: Boston
country: United States
facility: Massachusetts Gen Hosp
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health Ctr
state: Massachusetts
city: East Orange
country: United States
facility: VAMC New Jersey Healthcare System
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore Med Ctr
state: New Jersey
city: Somerville
country: United States
facility: Infectious Disease Assoc of Central Jersey
state: New Jersey
city: Jamaica
country: United States
facility: Biomedical Research Alliance of New York
state: New York
city: Manhasset
country: United States
facility: North Shore Univ Hosp
state: New York
city: New York
country: United States
facility: Liberty Medical
state: New York
city: New York
country: United States
facility: Mount Sinai Med Ctr
state: New York
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Galveston
country: United States
facility: Univ TX Galveston Med Branch
state: Texas
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
Study officials:
References: