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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002366




Registration number
NCT00002366
Ethics application status
Date submitted
2/11/1999
Date registered
31/08/2001
Date last updated
20/02/2009

Titles & IDs
Public title
The Safety and Effectiveness of Ritonavir in the Treatment of HIV-Related Kaposi's Sarcoma
Scientific title
A Phase II Safety and Activity Study of Ritonavir in the Treatment of HIV-Associated Cutaneous Kaposi's Sarcoma
Secondary ID [1] 0 0
M95-320
Secondary ID [2] 0 0
245C
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma, Kaposi 0 0
HIV Infections 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Inclusion Criteria

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:

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Henry's Hosp / Med Oncology - Sydney
Recruitment hospital [2] 0 0
Saint Vincent's Hosp Med Centre - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.
Trial website
https://clinicaltrials.gov/study/NCT00002366
Trial related presentations / 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)
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00002366