HIV InfectionsNCT00002011
The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
A study testing Methoxsalen in people with HIV Infections, run by Therakos at 1 site in United States.
Trial summary
To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Methoxsalen
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the following:
- Diagnosis of AIDS-related complex (ARC).
- Veins that can provide adequate access.
- Negative drug screen for drugs of abuse and zidovudine (AZT).
- Be willing to adhere to the protocol and sign a patient informed consent prior to study entry.
- Live within adequate commuting distance to the treatment center.
- Not be on any other investigational drug/device.
- Be 18 - 80 years old but minimum age requirements may be affected by state regulations or specific medical conditions.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment phase.
- Photosensitive disease, such as porphyria or systemic lupus erythematosus. Care must be taken in selecting patients who require drugs (either systemically or topically) during the course of the study with photosensitizing potential such as phenothiazines, tetracyclines, sulfonamides or chlorothiazide.
- Renal insufficiency with creatinine > 3 mg/dl.
- Symptoms of toxic effects (World Health Organization Criteria) resulting from previous therapy.
Show all 31Show fewer
- Severe emotional, behavioral or psychiatric problems that in the opinion of the investigator would result in poor compliance with the treatment regimen.
- Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
- History of or active Pneumocystis carinii pneumonia, other opportunistic infection or neoplasms (Kaposi's sarcoma), or wasting syndrome.
- Active hepatitis.
- Aphakia because of the significantly increased risk of retinal damage due to absence of lenses.
- Concurrent Medication:
- Excluded:
- Zidovudine (AZT).
- Photosensitizing drugs should not be administered prior to photopheresis treatment.
- Other investigational drugs.
- Concurrent Treatment:
- Excluded:
- Other treatment using an investigational device.
- Patients with the following are excluded:
- Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment phase.
- Photosensitive disease.
- Symptoms of toxic effects (World Health Organization Criteria) resulting from previous therapy.
- Severe emotional, behavioral or psychiatric problems that in the opinion of the investigator would result in poor compliance with the treatment regimen.
- Idiosyncratic or hypersensitivity reactions to 8-MOP compounds.
- Actively involved in drug abuse.
- Aphakia because of the significantly increased risk of retinal damage due to absence of lenses.
- Prior Medication:
- Excluded:
- Zidovudine (AZT).
- Actively involved in drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morristown Memorial Hosp
Morristown, New Jersey, 07962
About this study
To determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC).
Read the detailed description
Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two hours prior to each photopheresis session. The photopheresis instrument will separate the patient's white blood cells and some plasma from other blood components and return the majority of blood components to the patient. The separated white blood cells and plasma will be exposed to UVA (Ultraviolet A) light while outside the body. The UVA light photoactivates the 8-MOP drug which is now located in the DNA of the collected cells. After this exposure, the patients photoactivated white blood cells will be returned to the patient by venous access.
- Conditions
- HIV Infections
- Being tested
- Methoxsalen
- Keywords
- PUVA Therapy, Methoxsalen, AIDS-Related Complex
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxsalenDrug
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 N/A
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Therakos
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002011
- Sponsor's protocol ID
- 049A
- Status last verified
- Jul 1990
- 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
- The Therakos UVAR Photopheresis System in the Treatment of AIDS-Related Complex
- ClinicalTrials.gov ID
- NCT00002011
- Acronym / sponsor ID
- 049A
- Conditions
- HIV Infections
- Keywords
- PUVA Therapy, Methoxsalen, AIDS-Related Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- TherakosIndustry (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 determine the safety and patient tolerance of UVAR Photopheresis System (extracorporeal photopheresis) in the Treatment of AIDS-Related Complex (ARC).
Detailed description
Treatment involves the patient ingesting 8-methoxsalen (8-MOP) by mouth approximately two hours prior to each photopheresis session. The photopheresis instrument will separate the patient's white blood cells and some plasma from other blood components and return the majority of blood components to the patient. The separated white blood cells and plasma will be exposed to UVA (Ultraviolet A) light while outside the body. The UVA light photoactivates the 8-MOP drug which is now located in the DNA of the collected cells. After this exposure, the patients photoactivated white blood cells will be returned to the patient by venous access.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of AIDS-related complex (ARC).
- Veins that can provide adequate access.
- Negative drug screen for drugs of abuse and zidovudine (AZT).
- Be willing to adhere to the protocol and sign a patient informed consent prior to study entry.
- Live within adequate commuting distance to the treatment center.
Key exclusion criteria (31 listed)
- Inability to tolerate extracorporeal volume loss during the leukocyte-enrichment phase.
- Photosensitive disease, such as porphyria or systemic lupus erythematosus. Care must be taken in selecting patients who require drugs (either systemically or topically) during the course of the study with photosensitizing potential such as phenothiazines, tetracyclines, sulfonamides or chlorothiazide.
- Renal insufficiency with creatinine > 3 mg/dl.
- Symptoms of toxic effects (World Health Organization Criteria) resulting from previous therapy.
- Severe emotional, behavioral or psychiatric problems that in the opinion of the investigator would result in poor compliance with the treatment regimen.
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 |
|---|---|---|
| Methoxsalen | 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methoxsalen in people with HIV Infections, run by Therakos 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 8 inclusion and 31 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.
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.