Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00700115 · ClinicalTrials.gov registry record · Phase 4
Kaletra-isentress Treatment Evaluation
A Phase 4 study of HIV Infections, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00700115 is a Phase 4 study of HIV Infections that has completed, run by Emory University. The registered enrollment target is 60 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00700115, a Phase 4 study of HIV Infections, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Kaletra + Isentress
- DRUG Pre-study antiretroviral regimen
Study Locations (1)
Georgia
- Grady Infectious Diseases Program (Ponce Clinic) - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00700115
The ClinicalTrials.gov registry entry for NCT00700115 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (87% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Kaletra + Isentress is the first listed.
NCT00700115 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT00700115 about?
NCT00700115 is a clinical study titled "Kaletra-isentress Treatment Evaluation". 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...
What is the current status of trial NCT00700115?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2008-06. Estimated completion is 2011-01.
What conditions does trial NCT00700115 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT00700115?
The interventions under investigation include: Kaletra + Isentress (DRUG), Pre-study antiretroviral regimen (DRUG).
Who is sponsoring clinical trial NCT00700115?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00700115 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV Infections
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Accelerated ART Initiation for PWHIV Who Are Out of Care
RECRUITING · Phase 4
-
Vaccine Immunity and Inflammation in the Aging Person Living With HIV
RECRUITING · Phase 4
-
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
RECRUITING · Phase 4
-
Boosted Atazanavir and Truvada Given Once-Daily - BATON Study
COMPLETED · Phase 4
-
"The Once A Day Protease Inhibitor Regimens"
COMPLETED · Phase 4
-
Buprenorphine and Integrated HIV Care
COMPLETED · Phase 4
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.