Sarcoma, KaposiPhase 2NCT00002366
The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
A Phase 2 study testing Ritonavir in people with Sarcoma, Kaposi and HIV Infections, run by Abbott at 2 sites in Australia.
Trial summary
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Kaposi, HIV Infections
- What is being tested?
- Ritonavir
- How many people
- Not given
- Where
- 2 sitesAustralia
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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:
- Allowed:
- Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.
- Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
- Concurrent Treatment:
- Allowed:
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- Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
- Patients must have:
- Documentation of a positive ELISA test for HIV with a confirmatory test.
- Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.
- Vital signs, physical examination and laboratory assessments that exhibit no evidence of an acute illness.
- Patients must agree to report all current medications to the primary investigator and obtain prior permission to use them when feasible.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- Evidence of pulmonary Kaposi's sarcoma.
- Positive urine screen for recreational drugs.
- Current participation in another antiviral research study.
- Investigator anticipates poor patient compliance with the protocol.
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- Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.
- Concurrent Medication:
- Excluded:
- Antiretroviral therapy.
- Protease inhibitor therapy.
- Antiviral agent (e.g., oral ganciclovir or Foscarnet) or prophylactic medication for an AIDS defining illness which the patient cannot be removed from.
- Chemotherapy for Kaposi's sarcoma.
- Treatment with any medications that may interact with ritonavir.
- Concurrent Treatment:
- Excluded:
- Radiotherapy for Kaposi's sarcoma.
- Patients with any of the following prior conditions are excluded:
- History of psychiatric illness which is currently medically significant.
- History of pancreatitis.
- Prior Medication:
- Excluded:
- All antiretroviral therapy within 2 weeks prior to the start of the treatment phase of the study.
- Systemic chemotherapy of interferon within 30 days prior to study entry.
- Previous treatment with a protease inhibitor.
- Risk Behavior:
- Excluded:
- Active substance abuse.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Prince Henry's Hosp / Med Oncology
Sydney
Saint Vincent's Hosp Med Centre
Sydney
About this study
Official title: A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Being tested
- Ritonavir
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Ritonavir
- Medical subject headings
- Sarcoma, Kaposi, HIV Infections, Skin Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
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 (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoma, KaposiStudies 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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002366
- Sponsor's protocol ID
- 245C
- Other IDs
- M95-320
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
Publications
Carr A, Milliken S, Lewis C, Mitsuyasu R, Miles S, Newell M, Cooper DA. A pilot phase II safety and activity study of ritonavir in the treatment of HIV-associated cutaneous Kaposi's sarcoma. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:194 (abstract no 703)
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma
- ClinicalTrials.gov ID
- NCT00002366
- Acronym / sponsor ID
- 245C
- Conditions
- Sarcoma, Kaposi, HIV Infections
- Keywords
- Skin Neoplasms, Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, HIV Protease Inhibitors, Ritonavir
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (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 safety and anti-Kaposi's sarcoma activity of ritonavir.
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 (12 listed)
- Patients may receive oral acyclovir and may continue prophylactic treatment for PCP, fungal infection, MAC and toxoplasmosis.
- Topical treatment and intralesional chemotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
- Localized radiotherapy will be allowed for lesions which will not be used as indicator or biopsy lesions.
- Documentation of a positive ELISA test for HIV with a confirmatory test.
- Biopsy proven, cutaneous or oropharyngeal Kaposi's sarcoma.
Key exclusion criteria (28 listed)
- Evidence of pulmonary Kaposi's sarcoma.
- Positive urine screen for recreational drugs.
- Current participation in another antiviral research study.
- Investigator anticipates poor patient compliance with the protocol.
- Patient has any condition that, in the investigator's opinion, may obscure the proper observation of the safety or activity of ritonavir.
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 |
|---|---|---|
| Ritonavir | 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 20 Feb 2009.
- BackgroundCarr A, Milliken S, Lewis C, Mitsuyasu R, Miles S, Newell M, Cooper DA. A pilot phase II safety and activity study of ritonavir in the treatment of HIV-associated cutaneous Kaposi's sarcoma. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:194 (abstract no 703)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritonavir in people with Sarcoma, Kaposi and HIV Infections, run by Abbott at 2 sites in Australia.
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 12 inclusion and 28 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00002366, which also lists 1 linked publication.
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 20 Feb 2009.