HIV Clinical Trial
— KAARTOfficial title:
A Prospective Randomized Trial Comparing the Response of HIV Kaposi's Sarcoma (KS) to HAART Versus the Combination of HAART and Chemotherapy (CXT)
Verified date | March 2009 |
Source | University of KwaZulu |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 112 |
Est. completion date | March 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
South Africa | Department of Dermatology, King Edward VIII Hospital | Durban | Kwazulu Natal |
Lead Sponsor | Collaborator |
---|---|
University of KwaZulu | AIDS Care Research in Africa, AIDS Malignancy Consortium, Cipla Medpro, Dermatological Society of South Africa, National Research Foundation, Singapore |
South Africa,
Cassol E, Page T, Mosam A, Friedland G, Jack C, Lalloo U, Kopetka J, Patterson B, Esterhuizen T, Coovadia HM. Therapeutic response of HIV-1 subtype C in African patients coinfected with either Mycobacterium tuberculosis or human herpesvirus-8. J Infect Di — View Citation
Mosam A, Cassol E, Page T, Bodasing U, Cassol S, Dawood H, Friedland GH, Scadden DT, Aboobaker J, Jordaan JP, Lalloo UG, Esterhuizen TM, Coovadia HM. Generic antiretroviral efficacy in AIDS-associated Kaposi's sarcoma in sub-Saharan Africa. AIDS. 2005 Mar — View Citation
Mosam A, Goga Y, Thejpal R, Cassol E, Page T, Cassol S, Aboobaker J, Coovadia HM. Lymphadenopathy, pneumonia, and HIV--a common trio, an uncommon outcome. Lancet. 2005 Jan 15-21;365(9455):266. — View Citation
Peer FI, Pui MH, Mosam A, Rae WI. 99mTc-MIBI imaging of cutaneous AIDS-associated Kaposi's sarcoma. Int J Dermatol. 2007 Feb;46(2):166-71. — View Citation
Sebitloane HM, Mosam A, Moodley J. Disseminated AIDS-associated Kaposi's sarcoma in pregnancy. S Afr Med J. 2006 Jul;96(7):602-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical response of KS | 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. | 3 monthly | No |
Primary | Skin: tumour measurements of 5 indicator skin lesions. Assessment of KS as per AMC RKS 02 (www.amc.uab.edu) | 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 monthly | No |
Primary | photography of indicator lesions with metric tape in frame | Clinical photographs taken of marker lesions (5 according to AMC criteria) will be taken at baseline, month 6 and 12. | 6 monthly | No |
Primary | Visceral: chest radiograph and endoscopy, where necessary, bronchoscopy | done in patients who presented with visceral KS at baseline to monitor the disease | 6 monthly | No |
Secondary | Safety and toxicity by DAIDS Toxicity criteria | DAAIDS toxicity criteria used to assess and measure severity of adverse events | as they occur | Yes |
Secondary | Immunological and virological response to HAART as measured by CD4 and HIV-viral load | patients CD4 and VL will be measured 3 monthly to assess immunological and virological control | 3 monthly | No |
Secondary | QOL by EORTC QLQ C30 | EORTC QLQ C30 will be used as the tool to assess QOL in subjects | 3 monthly | No |
Secondary | Adherence | 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. | monthly | No |
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