A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
AIDS-Related Kaposi's Sarcoma |
Drug: abacavir/3TC/zidovudine Drug: abacavir /3TC plus ritonavir boosted lopinavir |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe |
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 49 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2A
co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks
|
Drug: abacavir/3TC/zidovudine
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
Other Names:
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:Completion of at least 96 weeks of treatment with ABC/3TC/ZDV on protocol Step 1.
- Currently receiving ABC/3TC/ZDV on Step 1/initial open-label allNRTI phase of study.
- Plasma HIV-1 RNA < 400 copies/mL on the most recent plasma HIV-1 RNA performed within 4 weeks of Step 2 entry.
- Willing to potentially switch to a new antiretroviral regimen.
- In the opinion of the site investigator currently has clinical evidence of active KS disease.
Exclusion Criteria
- None
Contacts and Locations| Zimbabwe | |
| University of Zimbabwe College of Health Sciences Department of Medicine | |
| Harare, Zimbabwe | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr Margaret Z Borok, University of Zimbabwe College of Health Sciences Department of Medicine |
| ClinicalTrials.gov Identifier: | NCT00834457 History of Changes |
| Other Study ID Numbers: | COL30512 |
| Study First Received: | February 2, 2009 |
| Last Updated: | February 2, 2009 |
| Health Authority: | Zimbabwe: Medical Research Council |
Keywords provided by Parirenyatwa Hospital:
|
AIDS-related Kaposi's sarcoma antiretroviral therapy |
Additional relevant MeSH terms:
|
Sarcoma, Kaposi AIDS-Related Opportunistic Infections Sarcoma Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Opportunistic Infections Infection HIV Infections Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Parasitic Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Lamivudine Abacavir Ritonavir Lopinavir Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013