HIVPhase 4KAARTNCT00380770
HIV/AIDS Kaposis Sarcoma: Comparison of Response to HAART vs HAART Plus CXT
A Phase 4 study testing Generic HAART Triomune : d4T, 3TC, NVP and Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV in people with HIV and AIDS, run by University of KwaZulu at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Kaposi's Sarcoma
- What is being tested?
- Generic HAART Triomune : d4T, 3TC, NVP and Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2003to Mar 2009
- Phase
- Phase 4
- 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
- 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
Who cannot join
- • Pregnancy or breastfeeding
- Fungating tumors of KS
- Symptomatic pulmonary KS
- Symptomatic GI tract KS
- Clinical evidence of peripheral neuropathy
- Clinical evidence of heart disease
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Department of Dermatology, King Edward VIII Hospital
Durban, KwaZulu-Natal, 4001
About this study
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)
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.
Read more
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.
Read the detailed description
DETAILED METHODOLOGY
PRIMARY OBJECTIVES:
1.To compare the clinical response of HIV KS at month 12 in patients treated with HAART alone with those treated with the combination of HAART and chemotherapy (CXT).
SECONDARY OBJECTIVES
- To monitor safety, tolerance and adverse events associated with each regimen.
- To compare the impact of each regimen at baseline and months 12 on:
- CD4 count
- HIV1 viral load in blood
- HIV disease progression
- To compare the impact of each regimen on the patients Quality of life (QOL).
- To compare the impact of each regimen on the patients adherence to HAART. 5 To measure and compare HHV8 viral load and HHV8 specific CTL responses at baseline and month 12 to each regimen.(in blood and tissue specimens )
DESIGN Prospective, randomized, open- labeled trial
RANDOMISATION Patients first staged into GOOD risk and POOR risk groups according to ACTG criteria. Thereafter 4 digit computer generated numbers after staging which assign patients to HAART alone or HAART plus CXT to ensure that equal numbers of GOOD and POOR risk patients are assigned to each group.
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.
INTERVENTION 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)
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.
This regimen will be given at 2 weekly intervals. This will be supplied by the Department of Oncology, KwaZulu Natal Province.
PRIMARY ENDPOINTS
- Clinical response of KS
- Clinical photographs taken of marker lesions (5 according to AMC criteria) will be taken at baseline, month 6 and 12.
- Lesion measurement of 5 marker lesions (as per AMC RKS 02 )(www.amc.uab.edu) will be done at baseline, month 3, month 6, month 9 and month 12. 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.
- The patients will be assessed by a specialist dermatologist, trained to use the above instruments, and will be the same individual so as to decrease bias introduced with inter-observer variability. We recognize that there is the potential for bias as the study is not blinded and dermatologist will know patient assignment. For that reason, we are using established objective criteria to evaluate response.
- Biopsies will be performed at baseline, month 6 and month 12 to assist in confirming response and to evaluate HIV and HHV8 tissue viral loads
- Safety and toxicity by DAIDS Toxicity criteria
- QOL by EORTC QLQ C30
- 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.
- Conditions
- HIV, AIDS, Kaposi's Sarcoma, Human Herpesvirus 8
- Being tested
- Generic HAART Triomune : d4T, 3TC, NVP, Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV
- Keywords
- HIV, AIDS, Kaposi's sarcoma, Human herpesvirus 8
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic HAART Triomune : d4T, 3TC, NVPDrug
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)
Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABVDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HAART alone | Experimental | 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) Receives: Drug: Generic HAART Triomune : d4T, 3TC, NVP |
| Combination HAART and chemotherapy | Active comparator | 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. Receives: Drug: Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 monthly
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.
Measured: 3 monthly
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.
Measured: 6 monthly
Visceral: chest radiograph and endoscopy, where necessary, bronchoscopy
done in patients who presented with visceral KS at baseline to monitor the disease
Measured: 6 monthly
Secondary outcomes (4)
Safety and toxicity by DAIDS Toxicity criteria
DAAIDS toxicity criteria used to assess and measure severity of adverse events
Measured: as they occur
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
Measured: 3 monthly
QOL by EORTC QLQ C30
EORTC QLQ C30 will be used as the tool to assess QOL in subjects
Measured: 3 monthly
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.
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startJan 2003
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of KwaZulu
- Sponsor type
- University, hospital or other
- Collaborators
- AIDS Care Research in Africa, National Research Foundation, Singapore, AIDS Malignancy Consortium, Cipla Medpro, Dermatological Society of South Africa
- Investigators
- Anisa Mosam, FC Derm,PhD, Principal investigator, Nelson R Mandela School of Medicine, University of Kwazulu Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380770
- Sponsor's protocol ID
- H029/02
- Acronym
- KAART
- Status last verified
- Mar 2009
- First submitted
- 25 Sep 2006
- Last updated
- 21 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sebitloane HM, Mosam A, Moodley J. Disseminated AIDS-associated Kaposi's sarcoma in pregnancy. S Afr Med J. 2006 Jul;96(7):602-3. No abstract available.
PubMed 16909181Mosam 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 4;19(4):441-3. doi: 10.1097/01.aids.0000161775.36652.85.
PubMed 15750399Mosam 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. doi: 10.1016/S0140-6736(05)17747-2. No abstract available.
PubMed 15652610Cassol 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 Dis. 2005 Feb 1;191(3):324-32. doi: 10.1086/427337. Epub 2004 Dec 22.
PubMed 15633090Peer 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. doi: 10.1111/j.1365-4632.2006.03001.x.
PubMed 17269969Shaik F, Uldrick TS, Esterhuizen T, Mosam A. Health-Related Quality of Life in Patients Treated With Antiretroviral Therapy Only Versus Chemotherapy and Antiretroviral Therapy for HIV-Associated Kaposi Sarcoma: A Randomized Control Trial. J Glob Oncol. 2018 Oct;4:1-9. doi: 10.1200/JGO.18.00105.
PubMed 30354935
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00380770
- Acronym / sponsor ID
- KAART / H029/02
- Conditions
- HIV, AIDS, Kaposi's Sarcoma, Human Herpesvirus 8
- Keywords
- HIV, AIDS, Kaposi's sarcoma, Human herpesvirus 8
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of KwaZuluUniversity, hospital or other
- Collaborators
- AIDS Care Research in Africa, National Research Foundation, Singapore, AIDS Malignancy Consortium, Cipla Medpro, Dermatological Society of South Africa
- Study start
- Jan 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Sep 2006 (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.
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.
Detailed description
DETAILED METHODOLOGY
PRIMARY OBJECTIVES:
1.To compare the clinical response of HIV KS at month 12 in patients treated with HAART alone with those treated with the combination of HAART and chemotherapy (CXT).
SECONDARY OBJECTIVES
- To monitor safety, tolerance and adverse events associated with each regimen.
- To compare the impact of each regimen at baseline and months 12 on:
- CD4 count
- HIV1 viral load in blood
- HIV disease progression
- To compare the impact of each regimen on the patients Quality of life (QOL).
- To compare the impact of each regimen on the patients adherence to HAART. 5 To measure and compare HHV8 viral load and HHV8 specific CTL responses at baseline and month 12 to each regimen.(in blood and tissue specimens )
DESIGN Prospective, randomized, open- labeled trial
RANDOMISATION Patients first staged into GOOD risk and POOR risk groups according to ACTG criteria. Thereafter 4 digit computer generated numbers after staging which assign patients to HAART alone or HAART plus CXT to ensure that equal numbers of GOOD and POOR risk patients are assigned to each group.
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.
INTERVENTION 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)
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.
This regimen will be given at 2 weekly intervals. This will be supplied by the Department of Oncology, KwaZulu Natal Province.
PRIMARY ENDPOINTS
- Clinical response of KS
- Clinical photographs taken of marker lesions (5 according to AMC criteria) will be taken at baseline, month 6 and 12.
- Lesion measurement of 5 marker lesions (as per AMC RKS 02 )(www.amc.uab.edu) will be done at baseline, month 3, month 6, month 9 and month 12. 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.
- The patients will be assessed by a specialist dermatologist, trained to use the above instruments, and will be the same individual so as to decrease bias introduced with inter-observer variability. We recognize that there is the potential for bias as the study is not blinded and dermatologist will know patient assignment. For that reason, we are using established objective criteria to evaluate response.
- Biopsies will be performed at baseline, month 6 and month 12 to assist in confirming response and to evaluate HIV and HHV8 tissue viral loads
- Safety and toxicity by DAIDS Toxicity criteria
- QOL by EORTC QLQ C30
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAART alone | Experimental | Drug: Generic HAART Triomune : d4T, 3TC, NVPArm 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) |
| Combination HAART and chemotherapy | Active comparator | Drug: Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABVArm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- • Pregnancy or breastfeeding
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 |
|---|---|---|
| Generic HAART Triomune : d4T, 3TC, NVPTriomune® (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 | HAART alone |
| Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABVTriomune® (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. | Drug | Combination HAART and chemotherapy |
Primary outcome
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.
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.
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.
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
4 secondary outcomes
Safety and toxicity by DAIDS Toxicity criteria
Time frame: as they occur
Immunological and virological response to HAART as measured by CD4 and HIV-viral load
Time frame: 3 monthly
QOL by EORTC QLQ C30
Time frame: 3 monthly
Adherence
Time frame: monthly
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 21 Jul 2010.
- Background: PubMed 16909181Sebitloane HM, Mosam A, Moodley J. Disseminated AIDS-associated Kaposi's sarcoma in pregnancy. S Afr Med J. 2006 Jul;96(7):602-3. No abstract available.
- Results publication: PubMed 15750399Mosam 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 4;19(4):441-3. doi: 10.1097/01.aids.0000161775.36652.85.
- Results publication: PubMed 15652610Mosam 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. doi: 10.1016/S0140-6736(05)17747-2. No abstract available.
- Results publication: PubMed 15633090Cassol 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 Dis. 2005 Feb 1;191(3):324-32. doi: 10.1086/427337. Epub 2004 Dec 22.
- Results publication: PubMed 17269969Peer 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. doi: 10.1111/j.1365-4632.2006.03001.x.
- Derived from this study: PubMed 30354935Shaik F, Uldrick TS, Esterhuizen T, Mosam A. Health-Related Quality of Life in Patients Treated With Antiretroviral Therapy Only Versus Chemotherapy and Antiretroviral Therapy for HIV-Associated Kaposi Sarcoma: A Randomized Control Trial. J Glob Oncol. 2018 Oct;4:1-9. doi: 10.1200/JGO.18.00105.
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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.
Anisa Mosam, FC Derm,PhD principal investigator
Nelson R Mandela School of Medicine, University of Kwazulu Natal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Generic HAART Triomune : d4T, 3TC, NVP and Generic HAART Triomune : d4T, 3TC, NVP and chemotherapy ABV in people with HIV and AIDS, run by University of KwaZulu at 1 site in South Africa.
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 7 inclusion and 13 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 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Clinical response of KS (time frame: 3 monthly). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00380770, which also lists 6 linked publications.
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 21 Jul 2010.