Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1
| Status: | Terminated |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | February 2009 |
| End Date: | October 2013 |
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
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.
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.
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.
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.
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)
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