NCT00834457

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 30, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

February 2, 2009

Last Update Submit

October 29, 2014

Conditions

AIDS-related Kaposi's Sarcoma

Keywords

AIDS-related Kaposi's sarcomaantiretroviral therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    96 weeks

Study Arms (2)

2A

ACTIVE COMPARATOR

co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg po(Trizivir)one tablet twice daily(BID)for 96 weeks

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

Drug: abacavir /3TC plus ritonavir boosted lopinavir

Interventions

abacavir/3TC/zidovudineDRUG

continued use of oral co-formulated abacavir 300mg/3TC 150mg/zidovudine 300mg for 96 weeks

Also known as: Trizivir
2A
abacavir /3TC plus ritonavir boosted lopinavirDRUG

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

Also known as: Kivexa or Epzicom, Aluvia
2B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zimbabwe College of Health Sciences Department of Medicine

Harare, Zimbabwe

Location

MeSH Terms

Conditions

AIDS-related Kaposi sarcoma

Interventions

abacavir, lamivudine, and zidovudine drug combinationabacavirabacavir, lamivudine drug combinationlopinavir-ritonavir drug combination

Study Officials

  • Margaret Z Borok, FRCP

    University of Zimbabwe College of Health Sciences Department of Medicine

    PRINCIPAL INVESTIGATOR

  • Thomas B Campbell, MD

    University of Colorado, Denver

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

June 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 30, 2014

Record last verified: 2014-10

Locations

ZI(1)