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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Secondary ID [2] 0 0
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

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Ritonavir

Treatment: Drugs: Ritonavir

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group


Key inclusion criteria
Inclusion Criteria

Concurrent Medication:


- 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:


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
Both males and females
Can healthy volunteers participate?
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:


- 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:


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:


- 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:


Active substance abuse.

Study design
Purpose of the study
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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
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

Ethics approval
Ethics application status

Brief summary
To evaluate the safety and anti-Kaposi's sarcoma activity of ritonavir.
Trial website
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

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
Other publications