Clinical trial NCT00834457: A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Official title: A Pilot Study Of the Effects of Highly Active Antiretroviral Therapy on Kaposi's Sarcoma in Zimbabwe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: AIDS-related Kaposi's Sarcoma
Keywords: AIDS-related Kaposi's sarcoma
antiretroviral therapy
Lead sponsor: Parirenyatwa Hospital
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: GlaxoSmithKline
name: Abbott
First posted: 2009-02-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
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.
timeFrame: 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: University of Zimbabwe College of Health Sciences Department of Medicine
Study officials:
affiliation: University of Zimbabwe College of Health Sciences Department of Medicine
name: Margaret Z Borok, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Thomas B Campbell, MD
role: STUDY_CHAIR
References: