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

Sponsor

Agouron Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00004985

Collaborator

(none)

Enrollment

Locations

2.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Capravirine Drug: Nelfinavir mesylate	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Body Positive	Phoenix	Arizona	United States	85016
2	Pacific Oaks Med Group	Beverly Hills	California	United States	90211
3	First Choice Medical	Palm Springs	California	United States	92262
4	Apogee Med Group	San Diego	California	United States	92101
5	Saint Francis Mem Hosp / HIV Care Unit	San Francisco	California	United States	94109
6	Kaiser Foundation Hospital	San Francisco	California	United States	94118
7	Harbor - UCLA Med Ctr	Torrance	California	United States	90502
8	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
9	Bach and Godofsky	Bradenton	Florida	United States	34205
10	Clin Research of West Florida	Clearwater	Florida	United States	33765
11	Community Health Care	Fort Lauderdale	Florida	United States	33306
12	Therafirst Med Ctr	Fort Lauderdale	Florida	United States	33308
13	Immunity Care and Research Inc	Miami Beach	Florida	United States	33139
14	South Shore Hosp	Miami	Florida	United States	33139
15	Orange County Health Dept	Orlando	Florida	United States	32805
16	Infectious Diseases Associates	Sarasota	Florida	United States	34239
17	Hillsborough County Health Dept	Tampa	Florida	United States	33602
18	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida	United States	32960
19	Polk County Health Dept	Winter Haven	Florida	United States	33881
20	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
21	Braude Mermin Spivey MD PC	Atlanta	Georgia	United States	30309
22	Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
23	Fenway Community Health Ctr	Boston	Massachusetts	United States	02115
24	VAMC New Jersey Healthcare System	East Orange	New Jersey	United States	07018
25	Jersey Shore Med Ctr	Neptune	New Jersey	United States	07753
26	Infectious Disease Assoc of Central Jersey	Somerville	New Jersey	United States	08876
27	Biomedical Research Alliance of New York	Jamaica	New York	United States	11432
28	North Shore Univ Hosp	Manhasset	New York	United States	11030
29	Liberty Medical	New York	New York	United States	10014
30	Mount Sinai Med Ctr	New York	New York	United States	10029
31	Central Texas Clinical Research	Austin	Texas	United States	78705
32	Univ TX Galveston Med Branch	Galveston	Texas	United States	77555
33	Infectious Disease Physicians Inc	Annandale	Virginia	United States	22203
34	Clinical Research Puerto Rico Inc	San Juan		Puerto Rico	009091711