A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease

Sponsor

OXO Chemie (Industry)

Overall Status

Completed

CT.gov ID

NCT00002244

Collaborator

(none)

240

Enrollment

Locations

7.5

Patients Per Site

Study Details

Study Description

Brief Summary

The purpose of this study is to see if it is safe and effective to give WF10 to adults with late-stage HIV disease. WF10 is suspected to help the immune system fight infection and slow HIV disease progression.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: WF10	Phase 3

Detailed Description

Patients are randomized to 1 of 2 treatment groups to receive 4 IV treatment cycles of either WF10 or control (physiological saline solution). Patients are monitored throughout the study for: a) clinical progression; b) number, duration, and cause of hospitalizations; c) quality of life; and d) density of CD38 antigen on CD8+ T cells. Patients receive treatment for 11 weeks but will continue to be followed for a maximum of 96 weeks. During the follow-up period, patients are evaluated initially at Week 18, then at Weeks 24, 36, and 48. If the study is continued beyond Week 48, follow-up visits are conducted at Weeks 72 and 96.

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pivotal Clinical Study Evaluating the Safety and Efficacy of WF10 (TCDO) Intravenous Solution in the Management of Patients With Late-Stage HIV Disease

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients may be eligible for this study if they:

Are HIV-positive.
Have a CD4 cell count of less than 50 cells/mm3 within 14 days prior to study entry.
Are at least 18 years old.
Have received anti-HIV drugs at some time in the past.
Agree to practice abstinence or use effective methods of birth control, including the pill, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

Are being treated for any form of cancer within 30 days of study entry.
Have ever received an HIV vaccine.
Have received steroids within 30 days prior to study entry. (Note: Testosterone is allowed.)
Have received certain medications, including anti-HIV treatments that are not approved by the FDA.
Have participated in another WF10 study.
Have an illness or any condition that might exclude them from this study.
Are pregnant or breast-feeding.
Abuse drugs or medications.
Received a blood transfusion within 45 days prior to study entry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Tower Infectious Disease Med Ctr	Los Angeles	California	United States	90048
3	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California	United States	946021018
4	ViRx Inc	San Francisco	California	United States	94103
5	UCSF - San Francisco Gen Hosp	San Francisco	California	United States	94110
6	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
7	Univ of Miami School of Medicine	Miami	Florida	United States	33136
8	Hillsborough County Health Dept	Tampa	Florida	United States	33602
9	Ctr for Quality Care	Tampa	Florida	United States	33609
10	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
11	Leahi Hosp / Univ of Hawaii	Honolulu	Hawaii	United States	96816
12	Northwestern Univ Med School	Chicago	Illinois	United States	60611
13	Rush Med Ctr / Section of Infectious Diseases	Chicago	Illinois	United States	60612
14	The CORE Ctr	Chicago	Illinois	United States	60612
15	Univ of Iowa Hosp & Clinic	Iowa City	Iowa	United States	52242
16	Boston Med Ctr / Clinical Research Office	Boston	Massachusetts	United States	02118
17	Univ Health Ctr	Detroit	Michigan	United States	48201
18	Regions Hosp	St. Paul	Minnesota	United States	55101
19	Truman Med Ctr / Infectious Disease Clinic	Kansas City	Missouri	United States	64108
20	Newark Community Health Ctr	Newark	New Jersey	United States	07114
21	Univ of New Mexico Health Science Center	Albuquerque	New Mexico	United States	87131
22	Associates in Med and Mental Health	Tulsa	Oklahoma	United States	74114
23	MCP Hahnemann Univ	Philadelphia	Pennsylvania	United States	19102
24	Ludwig Lettau Private Practice	Charleston	South Carolina	United States	29414
25	Burnside Clinic	Columbia	South Carolina	United States	29206
26	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666
27	Virginia Mason Research Center / Clinical Trial Unit	Seattle	Washington	United States	98101
28	St Paul's Hosp	Vancouver	British Columbia	Canada
29	QEII Health Science Centre	Halifax	Nova Scotia	Canada
30	Ottawa General Hospital	Ottawa	Ontario	Canada
31	Sunnybrook Health Science Ctr	Toronto	Ontario	Canada
32	Montreal Gen Hosp / Div of Clin Immuno and Allergy	Montreal	Quebec	Canada