HIV InfectionsPhase 1NCT00002119
A Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
A Phase 1 study testing WF10 in people with HIV Infections, run by Oxo Chemie GmbH at 1 site in United States.
Trial summary
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO. 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
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Concurrent Medication:
- Required:
- Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3.
- Allowed:
- PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200 cells/mm3, only at the discretion of the treating physician.
- Patients must have:
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- HIV positivity.
- Absolute CD4 count of 150 - 500 cells/mm3.
- At least 6 months of prior zidovudine therapy.
- No active opportunistic infection requiring ongoing therapy.
- Life expectancy of at least 6 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Neoplasm other than basal cell carcinoma of the skin.
- Clinically significant cardiac disease.
- Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
- Unwilling to comply with protocol requirements.
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- Patients with the following prior conditions are excluded:
- History of myocardial infarction or arrhythmias.
- Prior Medication:
- Excluded within 2 weeks prior to study entry:
- Antiretroviral agent or interferon.
- Systemic biologic response modifiers, corticosteroids, cytotoxic chemotherapeutic agents, or other drugs that can cause neutropenia or significant nephrotoxicity.
- Rifampin or rifampin derivatives.
- Systemic anti-infectives.
- Required:
- At least 6 months of prior zidovudine. Active drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.
- Conditions
- HIV Infections
- Being tested
- WF10
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Oxo Chemie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002119
- Sponsor's protocol ID
- 222A
- Other IDs
- WF10-92-US-001
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Busch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245)
Kahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423)
Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7. doi: 10.1007/BF02962364.
PubMed 9717676
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 Phase I/II Clinical Study of WF 10 IV Solution ( TCDO ) in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT00002119
- Acronym / sponsor ID
- 222A
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Oxo Chemie GmbHIndustry (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.
To evaluate the clinical toxicity, safety, and MTD of WF 10 ( TCDO ) intravenous solution administered to patients with HIV infection. To evaluate the potential anti-HIV activity of TCDO.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aerosolized pentamidine (300 mg monthly) as prophylaxis for PCP only in patients with CD4 count <= 200 cells/mm3.
- PCP prophylaxis with aerosolized pentamidine in patients with CD4 count > 200 cells/mm3, only at the discretion of the treating physician.
- HIV positivity.
- Absolute CD4 count of 150 - 500 cells/mm3.
- At least 6 months of prior zidovudine therapy.
Key exclusion criteria (16 listed)
- Neoplasm other than basal cell carcinoma of the skin.
- Clinically significant cardiac disease.
- Abnormal neurological status by a standardized assessment including strength, reflex testing, and sensory testing.
- Unwilling to comply with protocol requirements.
- History of myocardial infarction or arrhythmias.
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.
- BackgroundBusch HW, Christensen S, Reichelt D, Jahn S, Zidek W. Treatment of HIV-infected patients with advanced symptomatic disease with WF10 solution (TCDO). Int Conf AIDS. 1994 Aug 7-12;10(1):204 (abstract no PB0245)
- BackgroundKahn JO, McGrath MS, Ching OM, Kuhne FW. A single center, phase 2 study evaluating the effects of WF10. Int Conf AIDS. 1998;12:349 (abstract no 22423)
- Background: PubMed 9717676Raffanti SP, Schaffner W, Federspiel CF, Blackwell RB, Ching OA, Kuhne FW. Randomized, double-blind, placebo-controlled trial of the immune modulator WF10 in patients with advanced AIDS. Infection. 1998 Jul-Aug;26(4):202-7. doi: 10.1007/BF02962364.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WF10 in people with HIV Infections, run by Oxo Chemie GmbH at 1 site in United States.
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 11 inclusion and 16 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 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
On the ClinicalTrials.gov record for NCT00002119, which also lists 3 linked publications.
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.