AIDS-related Kaposi's SarcomaPhase 2/3NCT00834457
A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
A Phase 2/3 study testing abacavir/3TC/zidovudine and abacavir /3TC plus ritonavir boosted lopinavir in people with AIDS-related Kaposi's Sarcoma, run by Parirenyatwa Hospital at 1 site in Zimbabwe.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS-related Kaposi's Sarcoma
- What is being tested?
- abacavir/3TC/zidovudine and abacavir /3TC plus ritonavir boosted lopinavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteZimbabwe
- Study dates
- Jun 2007to Jul 2009
- Phase
- Phase 2/3
- 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
None listed.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
University of Zimbabwe College of Health Sciences Department of Medicine
Harare
About this study
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.
Read more
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.
Read the 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).
- Conditions
- AIDS-related Kaposi's Sarcoma
- Being tested
- abacavir/3TC/zidovudine, abacavir /3TC plus ritonavir boosted lopinavir
- Keywords
- AIDS-related Kaposi's sarcoma, antiretroviral therapy
- Medical subject headings
- AIDS-related Kaposi sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abacavir/3TC/zidovudineDrug
Also called Trizivir
continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks
abacavir /3TC plus ritonavir boosted lopinavirDrug
Also called Kivexa or Epzicom, Aluvia
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
| Study group | Role | What they receive |
|---|---|---|
| 2A | Active comparator | co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks Receives: Drug: abacavir/3TC/zidovudine |
| 2B | Active comparator | 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 Receives: Drug: abacavir /3TC plus ritonavir boosted lopinavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startJun 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDS-related Kaposi's SarcomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parirenyatwa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, GlaxoSmithKline, Abbott
- Responsible party
- Principal investigator, Margaret Borok, Parirenyatwa Hospital
- Investigators
- Margaret Z Borok, FRCP, Principal investigator, University of Zimbabwe College of Health Sciences Department of MedicineThomas B Campbell, MD, Study chair, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834457
- Sponsor's protocol ID
- COL30512
- Status last verified
- Oct 2014
- First submitted
- 2 Feb 2009
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
- ClinicalTrials.gov ID
- NCT00834457
- Acronym / sponsor ID
- COL30512
- Conditions
- AIDS-related Kaposi's Sarcoma
- Keywords
- AIDS-related Kaposi's sarcoma, antiretroviral therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Parirenyatwa HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, GlaxoSmithKline, Abbott
- Study start
- Jun 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 3 Feb 2009 (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.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2A | Active comparator | Drug: abacavir/3TC/zidovudineco-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks |
| 2B | Active comparator | Drug: abacavir /3TC plus ritonavir boosted lopinavirco-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| abacavir/3TC/zidovudineAlso: Trizivircontinued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks | Drug | 2A |
| abacavir /3TC plus ritonavir boosted lopinavirAlso: Kivexa or Epzicom, Aluviafixed 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 | Drug | 2B |
Primary outcome
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
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 30 Oct 2014.
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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.
Margaret Z Borok, FRCP principal investigator
University of Zimbabwe College of Health Sciences Department of Medicine
Thomas B Campbell, MD study chair
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing abacavir/3TC/zidovudine and abacavir /3TC plus ritonavir boosted lopinavir in people with AIDS-related Kaposi's Sarcoma, run by Parirenyatwa Hospital at 1 site in Zimbabwe.
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 0 inclusion and 1 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 30 Oct 2014. 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 Zimbabwe. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2014.