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Kaletra-isentress Treatment Evaluation

NCT00700115 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-12

Study results available
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Summary

This study will examine the effectiveness and safety of raltegravir (isentress) when used together with lopinavir/ritonavir (kaletra) for the treatment of HIV-infection. Isentress is a recently, Food and Drug Administration (FDA) approved, HIV medication that has strong effects against the HIV virus. Isentress has been shown in other studies to be safe and well tolerated by HIV patients. Combining this drug with kaletra might enable us to construct a HIV regimen that does not include the more toxic drugs of the nucleoside reverse transcriptase inhibitor class.

Eligible volunteers will undergo the following as part of the study procedure:

1. Sign the study consent form and the HIPAA Authorization Form.
2. Two-third of subjects, the intervention group (selected by random chance) will have their HIV drug treatment changed to kaletra + isentress.
3. The other one-third will continue their usual HIV medications (this will be the control group).
4. Make 9 study related visits to the Ponce clinic during the 48 weeks study period. During these visits, medical information will be collected, and blood tests will be performed.
5. Perform Dexa-scan on two separate occasions at Emory University Hospital Radiology.

Information collected will be used to assess the effectiveness of this treatment in keeping the HIV virus suppressed, how well these two drugs together is tolerated by HIV-infected patients, and the blood levels of these two drugs when given together.

Conditions

  • HIV Infections

Interventions

DRUG

Kaletra + Isentress

Kaletra 400/100 mg + Isentress 400 mg BID

DRUG

Pre-study antiretroviral regimen

Standard doses of pre-study antiretroviral regimen

Sponsors & Collaborators

Principal Investigators

  • Igho Ofotokun, MD, MSc · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700115 on ClinicalTrials.gov