HIV InfectionsPhase 3NCT00002244
A Study to Evaluate the Safety and Effectiveness of WF10 Given to Patients With Late-Stage HIV Disease
A Phase 3 study testing WF10 in people with HIV Infections, run by OXO Chemie at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- WF10
- How many people
- 240 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States27 sites
Univ of New Mexico Health Science Center
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, 02118
Ludwig Lettau Private Practice
Charleston, South Carolina, 29414
Northwestern Univ Med School
Chicago, Illinois, 60611
Rush Med Ctr / Section of Infectious Diseases
Chicago, Illinois, 60612
The CORE Ctr
Chicago, Illinois, 60612
Burnside Clinic
Columbia, South Carolina, 29206
Univ Health Ctr
Detroit, Michigan, 48201
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Leahi Hosp / Univ of Hawaii
Honolulu, Hawaii, 96816
Univ of Iowa Hosp & Clinic
Iowa City, Iowa, 52242
Truman Med Ctr / Infectious Disease Clinic
Kansas City, Missouri, 64108
Tower Infectious Disease Med Ctr
Los Angeles, California, 90048
Univ of Miami School of Medicine
Miami, Florida, 33136
Newark Community Health Ctr
Newark, New Jersey, 07114
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
MCP Hahnemann Univ
Philadelphia, Pennsylvania, 19102
Regions Hosp
Saint Paul, Minnesota, 55101
ViRx Inc
San Francisco, California, 94103
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, 98101
Hillsborough County Health Dept
Tampa, Florida, 33602
Ctr for Quality Care
Tampa, Florida, 33609
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Canada5 sites
QEII Health Science Centre
Halifax, Nova Scotia
Montreal Gen Hosp / Div of Clin Immuno and Allergy
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Sunnybrook Health Science Ctr
Toronto, Ontario
St Paul's Hosp
Vancouver, British Columbia
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- WF10
- Keywords
- Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WF10Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- OXO Chemie
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002244
- Sponsor's protocol ID
- 222C
- Status last verified
- Mar 2001
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002244
- Acronym / sponsor ID
- 222C
- Conditions
- HIV Infections
- Keywords
- Placebos, Infusions, Intravenous, Quality of Life, Anti-HIV Agents, tetrachlorodecaoxide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- OXO ChemieIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WF10 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing WF10 in people with HIV Infections, run by OXO Chemie at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.