Clinical trial NCT00781287: Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Keywords: human immunodeficiency virus
raltegravir
primary HIV infection
HIV-1
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-10-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Number of HIV-1 infected CD4+ T-cells measured by a quantitative HIV-1 DNA PCR assay
timeFrame: 96 weeks
Secondary outcomes:
measure: CD4+ T-cells
timeFrame: 96 weeks
measure: Plasma HIV-1 RNA
timeFrame: 96 weeks
measure: Grade 3 and 4 signs and symptoms or laboratory toxicities at least one grade higher than baseline
timeFrame: From study drug start to 8 weeks after drug discontinuation
measure: Plasma HIV-1 RNA
timeFrame: Baseline to Week 8
measure: Tolerability (Discontinuation of raltegravir)
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Primary Infection Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Ann C. Collier, MD
role: PRINCIPAL_INVESTIGATOR
References: