Phase 1 Pilot Study of an ART Bridging Regimen in Highly Experienced Patients Unable to Achieve Viral Suppression

NCT00336778 | Completed Phase 1 DMC

• 1 other identifier: H-22675
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• Change in replication capacity over time from baseline to week 48.

  Change in viral replication capacity

  48 weeks

Secondary Outcomes (3)

• Change in viral load from baseline to week 48.

  48 weeks

• Change in CD4 cell count from baseline to week 48.

  48 weeks

• Time to first Grade 3 sign, symptom, or lab abnormality,and/or OI that is at least a grade higher than baseline or a significant increase in viral load from baseline or a greater than 50% decline in CD4 cell count

  48 weeks

Interventions

3TC, TDF, NLV 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

University of Maryland Baltimore, Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

University of Maryland, Institute of Human Virology

Baltimore, Maryland, 21210, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Robert R Redfield, MD

  University of Maryland, College Park

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2006
• First Posted: June 14, 2006
• Study Start: January 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

US (2)