T-20 With Anti-HIV Combination Therapy for Patients With Prior Anti-HIV Drug Treatment and/or Drug Resistance to Each of the Three Classes of Approved Anti-HIV Drugs

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00008528

Collaborator

Trimeris (Industry)

525

Enrollment

Locations

14.2

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the change in viral load (amount of HIV in the blood) of patients who receive T-20 with selected anti-HIV drugs to that of patients who receive only selected anti-HIV drugs.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Enfuvirtide	Phase 3

Detailed Description

Eligible patients remain on their pre-study regimen until baseline. An OB regimen is chosen by the physician and patient based on the patient's prior treatment history, prior and current laboratory abnormalities, the screening GT/PT antiretroviral resistance testing, and any prior GT/PT antiretroviral resistance (if available). The drugs in the OB regimen are chosen from among the currently approved antiretrovirals and permitted newly approved/investigational antiretrovirals available in the countries where the study is implemented, and must consist of 3 to 5 drugs, including no more than 1 newly approved/investigational agent. Patients are stratified with respect to viral load and use (versus non-use) of any of the allowed newly approved/investigational antiretrovirals. Patients are randomized to receive 1 of the following 2 treatments for 48 weeks: OB or OB plus T-20. Patients are followed to assess viral load, safety, antiretroviral resistance, T-20 pharmacokinetics, and quality of life. At the end of 48 weeks of treatment patients are allowed to (a) roll over and receive OB plus T-20 (for patients receiving OB regimen alone) or (b) continue taking OB plus T-20 (for patients already receiving OB plus T-20), for an additional 48 weeks (plus 4 weeks safety follow-up period), or until 12 weeks after commercial availability of T-20 in the country in which they are treated, whichever comes first. All patients are followed in this study for a maximum of 100 weeks from their initial baseline visit date.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Phase III Open-Label, Randomized, Active-Controlled Study Assessing the Efficacy and Safety of T-20 (HIV-1 Fusion Inhibitor) in Combination With an Optimized Background Regimen, Versus Optimized Background Therapy Alone, in Patients With Prior Experience and/or Prior Documented Resistance to Each of the Three Classes of Approved Antiretrovirals (Nucleoside Reverse Transcriptase, Non-Nucleoside Reverse Transcriptase and Protease Inhibitors)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-infected.
Are at least 16 years old (have consent of parent or guardian if under 18).
Have a viral load (level of HIV in the blood) of 5,000 copies/ml or more.
Have received anti-HIV drugs for at least 6 months and/or have shown resistance to each of the 3 types of anti-HIV drugs as follows: nucleoside reverse transcriptase inhibitors (resistant to 1 or more); nonnucleoside reverse transcriptase inhibitors (resistant to 1 or more); and protease inhibitors (resistant to 2 or more, taken either together or 1 after the other for at least 6 months total).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	352942050
2	Phoenix Body Positive	Phoenix	Arizona	United States	85006
3	Pacific Oaks Med Group	Beverly Hills	California	United States	90211
4	AIDS Healthcare Foundation	Los Angeles	California	United States	900276069
5	Univ of California, San Diego	San Diego	California	United States	92103
6	San Francisco Gen Hosp	San Francisco	California	United States	94110
7	San Francisco VA Med Ctr	San Francisco	California	United States	94121
8	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
9	Whitman Walker Clinic/Elizabeth Taylor Med Ctr	Washington	District of Columbia	United States	20009
10	IDC Research Initiative	Altamonte Springs	Florida	United States	32701
11	Steinhart Medical Associates	Miami	Florida	United States	33133
12	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
13	Trevor Slom	Chicago	Illinois	United States	60611
14	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
15	New England Med Ctr	Boston	Massachusetts	United States	02111
16	Massachusetts Gen Hosp	Boston	Massachusetts	United States	02114
17	Community Research Initiative of New England	Brookline	Massachusetts	United States	02445
18	Regions Hosp	St. Paul	Minnesota	United States	55101
19	Albany Med College	Albany	New York	United States	12208
20	Peter Tsang	New York	New York	United States	10011
21	Columbia Presbyterian Med Ctr	New York	New York	United States	100323784
22	Univ of North Carolina / SOCA	Chapel Hill	North Carolina	United States	275997030
23	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
24	Case Western Reserve Univ / AIDS Clinical Trials Unit	Cleveland	Ohio	United States	44106
25	Oregon Health Sciences Univ	Portland	Oregon	United States	97201
26	MCP Hahnemann Univ	Philadelphia	Pennsylvania	United States	19102
27	Pennsylvania Oncology and Hematology Associates	Philadelphia	Pennsylvania	United States	19106
28	Univ of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
29	Vanderbilt Univ Med Ctr	Nashville	Tennessee	United States	37212
30	Nicholas Bellos	Dallas	Texas	United States	75246
31	Univ of Texas Med Branch	Galveston	Texas	United States	77555
32	Univ of Texas / Thomas Street Clinic	Houston	Texas	United States	77030
33	Univ of Washington / AIDS Clinical Trial Unit	Seattle	Washington	United States	98104
34	Vancouver Clinic	Vancouver	Washington	United States	98664
35	Toronto Gen Hosp	Toronto	Ontario	Canada
36	Centre Hospitalier de la Universite de Montreal (CHUM)	Montreal	Quebec	Canada
37	Clinique Medicale L'Actuele	Montreal	Quebec	Canada