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HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT (KAART)

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ClinicalTrials.gov Identifier: NCT00380770
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : July 21, 2010
Information provided by:

Study Description
Brief Summary:

Kaposi's sarcoma (KS)is the commonest malignancy associated with HIV/AIDS. Therapy for this cancer, which causes substantial morbidity, is suboptimal in resource poor settings. The reasons for this are: advanced state of immunosuppression when patients present for clinical care, concomitant opportunistic infections, non- availability of antiretroviral therapy (ART), non-availability and toxicity of chemotherapy (CXT), when available, in patients with full blown AIDS, prohibitive costs of bone marrow support and fiscal constraints in resource poor settings.

A recent Cochrane Review assessed the effectiveness of current therapeutic regimens for HIV KS, with a focus on options available in resource poor settings. The major selection criteria for this review were randomized controlled trials for HIV KS in adults. The main conclusions were that data from randomized controlled trials on effective treatments for HIV KS are sparse, particularly among people who are also taking highly active antiretroviral therapy (HAART). Alitretinoin gel is effective for therapy of cutaneous lesions, pegylated liposomal doxorubicin is effective for advanced KS and radiotherapy is effective for treating cutaneous lesions. Apart from the randomized trial of radiotherapy, no trials applicable to developing settings were identified. Therapy of HIV KS in developing countries thus remains unanswered.

The authors concluded that therapies discussed in the review are unlikely to be available or affordable in developing countries where the bulk of HIV infection and KS occur, apart from radiotherapy at a few tertiary centers. However, recent changes in pricing due to the global alliance and access initiatives mean that HAART is likely to be more available and accessible to developing countries in the near future. South Africa now has committed to this at cabinet level and had a task force to address this issue.

HAART has been proposed as therapy for HIV KS on the basis of restoring immune competence and minimizing the HIV tat drive to KS formation. It also improves immunologic control of HHV 8 possibly through interrupting the HIV-1- HHV-8 interaction.

There has been only one randomised trial conducted in Spain which compared HAART to the combination of HAART and CXT. There is to date no prospective, randomised controlled trial which compares the efficacy of HAART to the standard of care in HIV KS in Africa.

Condition or disease Intervention/treatment Phase
HIV AIDS Kaposi's Sarcoma Human Herpesvirus 8 Drug: Generic HAART Triomune : d4T, 3TC, NVP Drug: Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing the Response of HIV Kaposi's Sarcoma (KS) to HAART Versus the Combination of HAART and Chemotherapy (CXT)
Study Start Date : January 2003
Primary Completion Date : February 2009
Study Completion Date : March 2009

Arms and Interventions

Arm Intervention/treatment
Experimental: HAART alone
Arm 1. HAART These patients will be given one tablet twice daily of Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)
Drug: Generic HAART Triomune : d4T, 3TC, NVP
Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks)
Active Comparator: Combination HAART and chemotherapy
Arm 2. CTX PLUS HAART. HAART will be given as above. In addition, CTX will be administered at 2 weekly intervals in the Oncology Dept at KEH VIII Hospital and will consist of:- Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.
Drug: Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV
Triomune® (Cipla, Mumbai) Stavudine 40mg b.d > 60 kg , 30mg bd <60kg Lamivudine 150mg b.d > 50 kg 2mg/kg < 50 kg Nevirapine 200mg b.d ( 200mg daily for first 2 weeks) Intramuscular Bleomycin 10 U/m2 ; Intravenous Vincristine 1.4mg/m2 maximum 2mg and Intravenous Doxorubicin 20mg/m2.

Outcome Measures

Primary Outcome Measures :
  1. Clinical response of KS [ Time Frame: 3 monthly ]
    Responses will be categorized as complete response(only with biopsy confirmation), complete clinical response, partial response, stable disease and disease progression according to ACTG criteria.

  2. Skin: tumour measurements of 5 indicator skin lesions. Assessment of KS as per AMC RKS 02 (www.amc.uab.edu) [ Time Frame: 3 monthly ]
    Measurement of the same 5 marker lesions (as per AMC RKS 02 )will be done at baseline, month 3, month 6, month 9 and month 12. Assessed by bi-directional diameter.

  3. photography of indicator lesions with metric tape in frame [ Time Frame: 6 monthly ]
    Clinical photographs taken of marker lesions (5 according to AMC criteria) will be taken at baseline, month 6 and 12.

  4. Visceral: chest radiograph and endoscopy, where necessary, bronchoscopy [ Time Frame: 6 monthly ]
    done in patients who presented with visceral KS at baseline to monitor the disease

Secondary Outcome Measures :
  1. Safety and toxicity by DAIDS Toxicity criteria [ Time Frame: as they occur ]
    DAAIDS toxicity criteria used to assess and measure severity of adverse events

  2. Immunological and virological response to HAART as measured by CD4 and HIV-viral load [ Time Frame: 3 monthly ]
    patients CD4 and VL will be measured 3 monthly to assess immunological and virological control

  3. QOL by EORTC QLQ C30 [ Time Frame: 3 monthly ]
    EORTC QLQ C30 will be used as the tool to assess QOL in subjects

  4. Adherence [ Time Frame: monthly ]
    Adherence by 7 day adherence questionnaire Adherence will be measured using a standardized validated self administered questionnaire, which enables review of each medication during previous 7 days and a medication specific and overall adherence score.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Signed informed consent
  • Adults > 18 years
  • Documented HIV positive status (Confirmed by two ELISAs and HIV-1 RNA testing)
  • Willingness to use a barrier method of birth control throughout the course of the study, because of potential drug interactions that make oral contraceptives less effective (for women of childbearing potential) and sexually active males
  • Histologically proven
  • At least five measurable, previously unirradiated cutaneous lesions must be present which can be used as indicator lesions.
  • ECOG performance status 0-2

Exclusion Criteria:

  • • Pregnancy or breastfeeding

    • Fungating tumors of KS
    • Symptomatic pulmonary KS
    • Symptomatic GI tract KS
    • Clinical evidence of peripheral neuropathy
    • Clinical evidence of heart disease
    • Total neutrophil count of < 1,000u/L, Hemoglobin < 9.0gm/dl or platelet count of < 75,000u/L; serum creatinine > 1.5mgh/dl, direct serum bilirubin > 85 umol/l, AST or ALT > 2.5 time ULN.
    • Prior HAART ( to fairly evaluate antiretroviral response and KS response to HAART, patients should be antiretroviral naïve)
    • Prior radiation therapy for KS to sites of indicator lesions.
    • Prior cytotoxic chemotherapy for KS.
    • Concurrent neoplasia requiring cytotoxic therapy.
    • Life expectancy of < 3 months.
    • Circumstances, which in the opinion of the investigator make it unlikely the patient, can comply with the safety monitoring required for participation in this trial.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380770

South Africa
Department of Dermatology, King Edward VIII Hospital
Durban, Kwazulu Natal, South Africa, 4001
Sponsors and Collaborators
University of KwaZulu
AIDS Care Research in Africa
National Research Foundation, Singapore
AIDS Malignancy Consortium
Cipla Medpro
Dermatological Society of South Africa
Principal Investigator: Anisa Mosam, FC Derm,PhD Nelson R Mandela School of Medicine, University of Kwazulu Natal
More Information

Responsible Party: Dr Anisa Mosam, Department of Dermatology UKZN
ClinicalTrials.gov Identifier: NCT00380770     History of Changes
Other Study ID Numbers: H029/02
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: July 21, 2010
Last Verified: March 2009

Keywords provided by University of KwaZulu:
Kaposi's sarcoma
Human herpesvirus 8

Additional relevant MeSH terms:
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers