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| Sponsor: | The University of North Carolina, Chapel Hill |
|---|---|
| Collaborators: |
Bristol-Myers Squibb Gilead Sciences |
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00924898 |
Purpose
This is a pilot study of treatment of acute HIV infection with a once daily regimen of Emtricitabine, Tenofovir and Efavirenz. The primary objectives of this study are:
| Condition | Intervention | Phase |
|---|---|---|
|
Acute HIV Infection HIV Infections |
Drug: Atripla |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | CID 0805 - Treatment of Acute HIV Infection With a Once Daily Regimen of Emtricitabine, Tenofovir and Efavirenz - A Pilot Study of Response to Therapy and HIV Pathogenesis |
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Hypothesis: Once daily HAART with FTC/TDF (FDC, Truvada) + EFV administered as a single dose pill called Atripla will reduce viral replication to <400 copies RNA/ml plasma in blood and other body compartments in patients with acute HIV infection, reducing infectivity, and permitting generation of HIV-specific immune responses. The treatment regimen will be well tolerated and any lipid profile changes will be modest during treatment follow-up. A coordinated program of counseling and support will facilitate adherence and promote successful therapy. Prevalence of transmitted drug resistant HIV-1 will be assessed.
Study Design: Multi-center, prospective, single-arm pilot study of FTC/TDF/EFV in patients with acute HIV infection. Study sites will be members of the Duke-UNC Acute HIV Infection Study Consortium. Patients will be followed intensively for the first year with continued follow-up for an additional year pending developments on treatment cessation approaches for patients with suppressed virus and effective immune responses.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following laboratory parameters verified within 30 days of study entry:
CrCl = (140-age) x body weight (kg) (x 0.85 if female) Serum creatinine [mg/dL] x (72)
Exclusion Criteria:
Concomitant Medications:
Contacts and Locations| Contact: JoAnn Kuruc | 919-966-8533 | joann_kuruc@med.unc.edu |
| United States, North Carolina | |
| The University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: Cynthia Gay, MD, MPH | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27707 | |
| Principal Investigator: Charles Hicks, MD | |
| Principal Investigator: | Cynthia Gay, MD, MPH | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | The University of North Carolina, Chapel Hill ( Cynthia Gay, MD, MPH ) |
| Study ID Numbers: | CID 0805 (PHI 02) |
| Study First Received: | June 17, 2009 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00924898 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Acute HIV HIV Acute Infections Acute Infection |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
Efavirenz RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |