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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004985
• Other study ID #: 286D
• Secondary ID: AG1549-509
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2000
• Last updated: June 23, 2005
• Start date: January 2000

Study information

• Verified date: March 2001
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Capravirine

• Nelfinavir mesylate

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Agouron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico,