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Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 (UW PIC 330)
This study has been terminated.
(Enrollment too slow.)
Sponsor:
University of Washington
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Ann Collier, University of Washington
ClinicalTrials.gov Identifier:
NCT00781287
First received: October 24, 2008
Last updated: August 8, 2013
Last verified: August 2013
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Purpose
This is an investigator-initiated, two-year, randomized, controlled, single-center, open-label, pilot study comparing 3-drug highly active antiretroviral therapy (HAART) to 3-drug HAART plus raltegravir for persons with acute and early HIV-1 infection. The study will test the hypothesis that use of the integrase inhibitor raltegravir (400 mg BID orally) to inhibit the integration step of the HIV-1 life cycle in conjunction with HAART in subjects with recently acquired HIV-1 infection will decrease the number of HIV-1 infected CD4+ T-cells to a greater extent than a 3-drug HAART regimen.
| Condition | Intervention | Phase |
|---|---|---|
| Human Immunodeficiency Virus | Drug: 3-drug anti-HIV therapy Drug: Raltegravir | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Impact of Raltegravir (Isentress/MK-0518) - Containing Regimens on HIV-1 Infected CD4+ T-Cells During Acute and Early HIV-1 Infection: A Randomized, Controlled Study Comparing Standard Antiretroviral Therapy to Standard Therapy Plus Raltegravir |
Resource links provided by NLM:
Further study details as provided by Ann Collier, University of Washington:
Primary Outcome Measures:
- Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay [ Time Frame: 96 weeks ]
Secondary Outcome Measures:
- CD4+ T-cells [ Time Frame: 96 weeks ]
- Plasma HIV-1 RNA [ Time Frame: 96 weeks ]
- Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline [ Time Frame: From study drug start to 8 weeks after drug discontinuation ]
- Plasma HIV-1 RNA [ Time Frame: Baseline to Week 8 ]
- Tolerability (Discontinuation of raltegravir) [ Time Frame: 96 weeks ]
| Enrollment: | 10 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | October 2013 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Raltegravir + 3-drug anti-HIV therapy |
Drug: 3-drug anti-HIV therapy
3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
Drug: Raltegravir
400 mg BID PO
Other Name: Isentress
|
| Active Comparator: 3-drug anti-HIV therapy |
Drug: 3-drug anti-HIV therapy
3 FDA-approved drugs, including two nucleos(t)ide reverse transcriptase inhibitors and either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor (Low dose ritonavir can be used to enhance the protease inhibitor and is not considered one of the 3 anti-HIV drugs)
|
Detailed Description:
The study will be conducted at the UW Primary Infection Clinic and the UW AIDS Clinical Trials Unit. Secondary objectives will characterize safety, tolerability, plasma HIV-1 RNA and CD4+ T-cell values. The 3-drug HAART will be chosen and provided by the subject.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute or Early HIV-1 infection
- HIV-1 RNA > or equal to 500 copies/mL
- Acceptable safety lab results (specified in protocol)
- Negative pregnancy test for females
- Willingness to use contraception (for females of reproductive potential
Exclusion Criteria:
- Prior receipt of investigational HIV-1 vaccine
- Use of immunomodulators other than systemic steroids within 30 days before entry
- Serious medical or psychiatric illness that would interfere with study participation
- Active drug or alcohol use that would interfere with study participation
- Allergy/hypersensitivity to raltegravir
- Pre- or Post-exposure prophylaxis for the exposure that led to HIV-1 acquisition
- Pregnancy or breastfeeding
- History of malignancy (other than localized squamous cell or basal cell cancer of the skin)
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00781287
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781287
Locations
| United States, Washington | |
| University of Washington Primary Infection Clinic | |
| Seattle, Washington, United States, 98195 | |
Sponsors and Collaborators
University of Washington
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Ann C. Collier, MD | University of Washington |
More Information
Additional Information:
| Responsible Party: | Ann Collier, Professor of Medicine, University of Washington |
| ClinicalTrials.gov Identifier: | NCT00781287 History of Changes |
| Other Study ID Numbers: |
34908-D |
| Study First Received: | October 24, 2008 |
| Last Updated: | August 8, 2013 |
Keywords provided by Ann Collier, University of Washington:
|
human immunodeficiency virus raltegravir primary HIV infection HIV-1 |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017