A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
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|ClinicalTrials.gov Identifier: NCT00834457|
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : October 30, 2014
Open-label study of a regimen of antiretrovirals for the treatment of AIDS-KS. This study will be conducted at a single site, the Parirenyatwa Hospital KS Clinic.
Step 1 was conducted to determine the extent of clinical resolution of AIDS-KS disease in response to treatment with antiretroviral therapy and to investigate whether clinical resolution of KS is associated with suppression of KSHV replication.
Step 2 was developed to then evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression an all NRTI regimen.
Step 3 was included to evaluate the clinical, immunological, and virological effects of intensification with a ritonavir-boosted protease inhibitor in persons with AIDS-KS who have virological failure on an all NRTI regimen.
|Condition or disease||Intervention/treatment||Phase|
|AIDS-related Kaposi's Sarcoma||Drug: abacavir/3TC/zidovudine Drug: abacavir /3TC plus ritonavir boosted lopinavir||Phase 2 Phase 3|
To identify factors associated with successful treatment of KS with antiretroviral therapy and to determine if highly active antiretroviral therapy improves survival and quality of life for persons with AIDS-KS in Zimbabwe.
A secondary objective is to investigate the durability of HIV-1 suppression by the combination of ABC/3TC/ZDV in persons infected with HIV-1 subtype C and to evaluate the timing and characteristics of mutations in HIV-1 reverse transcriptase in subjects who fail to achieve, or to maintain suppression of HIV-1 replication during treatment with ABC/3TC/ZDV.
An important objective is to assess adherence to a simplified antiretroviral regimen in a resource-limited setting.
The study will evaluate the clinical, immunological, and virological effects of a switch from a twice-daily all-nucleoside reverse transcriptase inhibitor (NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a ritonavir-boosted protease inhibitor in persons with AIDS-KS and good virologic suppression on ABC/3TC/ZDV (see above).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
U.S. FDA Resources
Active Comparator: 2A
co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
Other Name: Trizivir
Active Comparator: 2B
co-formulated abacavir 600mg/3TC 300mg orally (as Kivexa) one tablet daily plus fixed dose lopinavir 133.3mg/ritonavir 33.3mg orally (as Aluvia) four tablets daily for 96 weeks
Drug: abacavir /3TC plus ritonavir boosted lopinavir
fixed dose abacavir 600mg/3TC 300mg one tablet po QD for 96 weeks plus fixed dose ritonavir 33.3mg/lopinavir 133.3mg four tablets po QD for 96 weeks
- Compare effects of twice-daily all-(NRTI) antiretroviral regimen to a once-daily regimen of 2 NRTIs plus a protease inhibitor AIDS-KS subjects with good virologic suppression on all-NRTI regimen. [ Time Frame: 96 weeks ]
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): NCT00834457
|University of Zimbabwe College of Health Sciences Department of Medicine|
|Principal Investigator:||Margaret Z Borok, FRCP||University of Zimbabwe College of Health Sciences Department of Medicine|
|Study Chair:||Thomas B Campbell, MD||University of Colorado, Denver|