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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00667433

Run by

David A Wohl, MD

People needed

38

Starts

2008-06-01

Expected to finish

2011-12-01

Last updated by the study team

2017-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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