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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CD4+ T-cells [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- Plasma HIV-1 RNA [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Plasma HIV-1 RNA [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
- Tolerability (Discontinuation of raltegravir) [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
| 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) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 27, 2016