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| Sponsor: | Rockefeller University |
|---|---|
| Collaborators: |
Aaron Diamond AIDS Research Center Merck Pfizer |
| Information provided by: | Rockefeller University |
| ClinicalTrials.gov Identifier: | NCT00525733 |
Purpose
The researchers are involved in a phase II, randomized, two-arm study, comparing the efficacy, safety, and tolerability of open-label ritonavir (RTV)-enhanced darunavir with Truvada to a 5-drug multi-class regimen including truvada, darunavir/ritonavir/maraviroc/and raltegravir on acutely HIV-1-infected, antiretroviral (ARV) drug-naïve men and women. Subjects will participate for at least 60 weeks and up to 96 weeks if in the opinion of the investigator and patient that continued therapy is in the patient's best interest.
Hypotheses:
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: darunavir Drug: Emtricitabine/tenofovir DF Drug: Maraviroc Drug: Raltegravir |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II, Randomized Trial of Open-Label Truvada With Darunavir/Ritonavir Versus Multiclass Therapy With Truvada, Darunavir/Ritonavir, Maraviroc and Raltegravir in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm A: Active Comparator
FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
|
Drug: darunavir
Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Drug: Emtricitabine/tenofovir DF
Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
|
|
Arm B: Experimental
FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
|
Drug: darunavir
Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)
Drug: Emtricitabine/tenofovir DF
Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)
Drug: Maraviroc
Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)
Drug: Raltegravir
Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)
|
ARM A: FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD
ARM B: FTC 200 mg/TDF 300 mg QD + darunavir 800mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID
The three primary objectives are:
To assess whether a multi-class regimen could completely suppress virus replication in HIV infected individuals based on:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Acute HIV-1 infection defined as:
The only exceptions are:
Laboratory values obtained within 30 days prior to study entry.
Gault equation:
For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)*
Contraception requirements:
Male Candidates:
Exclusion Criteria:
NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restriction.
Contacts and Locations| Contact: Don Garmon, NP | 212-327-7290 | dgarmon@adarc.org |
| United States, New York | |
| Rockefeller University | Recruiting |
| New York, New York, United States, 10021 | |
| Principal Investigator: Martin Markowitz, MD | |
| Principal Investigator: | Martin Markowitz, MD | Rockefeller University |
More Information
| Responsible Party: | Rockefeller University ( Martin Markowitz ) |
| Study ID Numbers: | MMA-0610-0607 |
| Study First Received: | September 5, 2007 |
| Last Updated: | November 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00525733 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HIV-1 Acute Infection Treatment Naive |
|
Communicable Diseases Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Darunavir Reverse Transcriptase Inhibitors Emtricitabine Anti-Retroviral Agents Therapeutic Uses Tenofovir Retroviridae Infections Nucleic Acid Synthesis Inhibitors Tenofovir disoproxil |
HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections |