Overview

Raltegravir as Early Therapy in African-Americans Living With HIV Study

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
Summary
This is a single arm, longitudinal study to examine the safety, tolerability, and pharmacokinetic and metabolic characteristics of Raltegravir among 40 African-American, HIV-infected, patients.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
David A Wohl, MD
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Raltegravir Potassium
Tenofovir
Criteria
Inclusion Criteria:

- HIV-1 infection documented by HIV serology or detectable viral load

- Self-described as African-American

- Less than 7 days cumulative of prior HIV therapy

- Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to
study entry

- Able to provide informed consent

- In the opinion of the investigator, able to comply with study medication and
procedures

- ALT (SGPT) < or equal to 3.0 x ULN within 45 days prior to study entry

- GRF > 59 as calculated by MDRD within 45 days prior to study entry

- All women of reproductive potential (who have not reached menopause or undergone
hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum or
urine β-HCG pregnancy test performed within 48 hours before entry.

All study volunteers must agree not to participate in a conception process (e.g., active
attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and,
if participating in sexual activity that could lead to pregnancy, the female study
volunteer/male partner must use at least one reliable method of contraception (e.g.,
condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide;
an IUD; or hormonal-based contraception), simultaneously while receiving the
protocol-specified medication(s) and for 6 weeks after stopping the medication(s). If oral
birth control pills, hormone patches, or hormone injections are used for contraception,
then a second method of contraception must be used.

Exclusion Criteria:

- Pregnancy

- Breastfeeding

- Prior receipt of Raltegravir

- Any condition which in the opinion of the investigator is likely to interfere with
follow-up or ability to take the study medication appropriately