Status:
COMPLETED
Phase 1 Pilot Study of an ART Bridging Regimen in Highly Experienced Patients Unable to Achieve Viral Suppression
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
We hypothesize that a simple bridging ARV regimen that tends to select for virus with a low replicative capacity may tend to stabilize CD4 cell counts and HIV viral load and might be an option to cons...
Detailed Description
Bridge is a pilot, single-arm, open-label, study to assess the ability of 3 FDA approved anti-retroviral drugs to decrease replication capacity of HIV virus in order to stabilize CD4 cell count and HI...
Eligibility Criteria
Inclusion
- Men and women age \> 18 years of age.
- Ability and willingness to give written informed consent.
- HIV-1 infection as documented by any licensed ELISA test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA prior to study entry.
- Patient failed multiple treatment regimens due to development of viral resistance/and or intolerance.
- Patient's provider feels that patient has exhausted currently available treatment options and that it is highly unlikely that a regimen (including one that contains T-20) could be constructed that would result in sustained virologic suppression at this time.
- Evidence of MDR virus (broad 3 class resistance) based on the results of the MDR-HIV qualifying screening genotypic resistance test or a history of a previous genotypic resistance test.
- The following screening laboratory values obtained within 30 days prior to study entry:
- HIV-1 RNA or BDNA \> 10,000 copies/mL
Exclusion
- Active drug or alcohol abuse or dependence which, in the opinion of the investigator, would interfere with adherence to study requirements.
- History of any illness that, in the opinion of the study investigators, might confound the results of the study or pose additional risk in administering study drugs to the subject.
- Acute therapy for a serious infection or other serious medical illnesses that are potentially life threatening and require systemic therapy and/or hospitalization.
- NOTE: Subjects with a serious infection or serious medical illness must complete acute therapy at least 7 days prior to study entry. Subjects with all other infections or medical illnesses (e.g., vaginitis, folliculitis, bronchitis, pharyngitis, thrush) must receive appropriate therapy prior to study entry (no time restriction).
- Significant Renal Insufficiency - calculated creatinine clearance \< 50
- Upon reviewing medication history and genotypic resistance testing, study investigators feel that would be inappropriate to enroll patient in this protocol.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00336778
Start Date
January 1 2004
End Date
April 1 2008
Last Update
May 11 2021
Active Locations (2)
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1
University of Maryland Baltimore, Institute of Human Virology
Baltimore, Maryland, United States, 21201
2
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States, 21210