Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1 (UW PIC 330)
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ClinicalTrials.gov Identifier: NCT00781287 |
Recruitment Status
:
Terminated
(Enrollment too slow.)
First Posted
: October 28, 2008
Last Update Posted
: August 12, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Human Immunodeficiency Virus | Drug: 3-drug anti-HIV therapy Drug: Raltegravir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | February 2012 |
Estimated Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
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)
|
- Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay [ Time Frame: 96 weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781287
United States, Washington | |
University of Washington Primary Infection Clinic | |
Seattle, Washington, United States, 98195 |
Principal Investigator: | Ann C. Collier, MD | University of Washington |
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 |
First Posted: | October 28, 2008 Key Record Dates |
Last Update Posted: | August 12, 2013 |
Last Verified: | August 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 |