Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Maryland |
---|---|
Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00336778 |
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 consider in patients with MDR HIV.
This strategy will provide them with the bridge they desperately need so that they can await the development of new therapies that when used in combination will give them the best chance in achieving complete virologic suppression.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: 3TC 300 mg PO once daily+ TDF 300 mg PO once daily+ NLV 1250 mg PO twice daily (after 12 week lead-in period) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase I Pilot Study Of An Antiretroviral Bridgeing Regimen In Highly Experienced Patients Unable To Achieve Viral Suppression. |
Estimated Enrollment: | 12 |
Study Start Date: | January 2004 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
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 HIV RNA viral loads . All subjects will be prescribed the three-drug combination of lamivudine (3TC) + tenofovir disoproxil fumarate (TDF) + nelfinaivr (NLV)The "Bridge Study" is a pilot, 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 HIV RNA viral loads. All subjects will receive the three-drug combination of lamivudine (3TC)+tenofovir disoproxil fumarate(TDF)+nelfinavir (NLV)
The study will enroll 12 subjects for a 48 week study. Major entry criteria include: HIV+ Men and women 18 years of age who are currently failing antiretroviral(ARV)therapy with an HIV-1 RNA VL > 10,000 and have failed multiple treatment regimens due to resistance and/or intolerance. Genotype must demonstrate resistance to 3 major classes of ARV's - PI's, NNRTI's, and NRTI's.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following screening laboratory values obtained within 30 days prior to study entry:
Exclusion Criteria:
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).
United States, Maryland | |
University of Maryland, Institute of Human Virology | |
Baltimore, Maryland, United States, 21210 | |
University of Maryland Baltimore, Institute of Human Virology | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Ronald B Reisler, MD, MPH | University of Maryland |
Study Director: | Robert R Redfield, MD | University of Maryland |
Study ID Numbers: | H-22675 |
Study First Received: | June 12, 2006 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00336778 |
Health Authority: | United States: Institutional Review Board |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Lamivudine Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |