HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy
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ClinicalTrials.gov Identifier: NCT00709397 |
Recruitment Status
:
Terminated
(lack of accrual)
First Posted
: July 3, 2008
Last Update Posted
: August 2, 2010
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Condition or disease | Intervention/treatment |
---|---|
HIV-1 Infection | Other: blood drawing |
Study Type : | Observational |
Actual Enrollment : | 3 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | HIV-1 Viral Dynamics in Subjects Initiating Raltegravir Therapy |
Study Start Date : | June 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Observation
antiretroviral-experienced patients requiring raltegravir to construct an adequately potent antiretroviral regimen.
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Other: blood drawing
Subjects will have been prescribed raltegravir (400 mg BID) by their primary physicians. Such subjects will have frequent blood sampling in this study to monitor the virologic response to raltegravir therapy.
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- first- and second-phase decay rates of plasma HIV-1 RNA [ Time Frame: 24 weeks ]
- 1. As exploratory analyses, to compare the observed first-phase decay rate of plasma HIV-1 RNA in treatment-experienced patients receiving raltegravir to treatment-naïve patients in other studies. [ Time Frame: 24 weeks ]
- 2. Quantify changes in the intracellular levels of HIV-1 proviral DNA and LTR circles during raltegravir therapy. [ Time Frame: 24 weeks ]
- 3. Correlate changes in the intracellular DNA compartments with first- and second-phase plasma HIV-1 RNA clearance rates. [ Time Frame: 24 weeks ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HIV-infected patients age 18 years or older requiring treatment with raltegravir in order to construct an adequately active antiretroviral regimen.
- Availability of at least two other drugs expected to have full activity based on genotypic and/or phenotypic drug resistance testing, a co-receptor tropism assay, or first use of a drug from a previously unused class of antiretroviral drugs (e.g., first use of enfuvirtide).
- Plasma HIV-1 RNA >10,000 copies/mL at screening (within 6 weeks of study entry).
- Negative serum or urine pregnancy test at screening and within 48 hours prior to entry for women with reproductive potential
- Ability and willingness of subject or legal guardian/representative to provide informed consent.
Exclusion Criteria:
- Pregnancy or breast-feeding.
- Previous treatment with any approved or investigational strand-transfer integrase inhibitor at any time prior to study entry.
- Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
- Any subject with an acute AIDS-defining opportunistic infection (OI) who is not clinically stable or who has not been on therapy for the OI for at least 30 days prior to study entry. Subjects who have no evidence of active disease and are receiving maintenance therapy for AIDS-related OIs will be eligible.
- Treatment within 30 days prior to study entry with immune modulators such as systemic steroids, interleukins, interferons, granulocyte colony-stimulating factor (G-CSF), erythropoietin, or any investigational therapy.
NOTE: Subjects receiving stable physiologic glucocorticoid doses, defined as prednisone ≤ 10 mg/day (or equivalent) as a stable or tapering dose, will be permitted. Subjects receiving corticosteroids for acute therapy forPneumocystis jaroveci pneumonia (PCP) or asthma exacerbation, or receiving a short course (defined as ≤ 2 weeks of pharmacologic glucocorticoid therapy) will not be excluded.
• Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry.
NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restriction.
• Substance abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements.who have limited or no treatment options due to extensive antiretroviral drug resistance or drug intolerance.

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): NCT00709397
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Daniel R Kuritzkes, MD | Brigham and Women's Hospital |
Responsible Party: | Daniel R. Kuritzkes, MD, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00709397 History of Changes |
Other Study ID Numbers: |
2007-P-002410/1 |
First Posted: | July 3, 2008 Key Record Dates |
Last Update Posted: | August 2, 2010 |
Last Verified: | July 2010 |
Keywords provided by Brigham and Women's Hospital:
HIV-1 drug resistance raltegravir integrase inhibitor |
Additional relevant MeSH terms:
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 |