Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781287

Acronym

UW PIC 330

Enrollment

Registered

2008-10-28

Start date

2009-02-28

Completion date

2013-10-31

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus

Keywords

human immunodeficiency virus, raltegravir, primary HIV infection, HIV-1

Brief summary

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.

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.

Interventions

DRUG3-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)

DRUGRaltegravir

400 mg BID PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay	96 weeks

Secondary

Measure	Time frame
CD4+ T-cells	96 weeks
Plasma HIV-1 RNA	96 weeks
Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline	From study drug start to 8 weeks after drug discontinuation
Tolerability (Discontinuation of raltegravir)	96 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026