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

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose: This study will be a single arm, prospective cohort study to examine the safety, efficacy, and pharmacokinetic and metabolic characteristics of Raltegravir in African-American men and women. Participants: 40 HIV positive, ARV treatment-naive, African-American women and men (estimated to be 70% men, 30% women) Procedures (methods): Subjects will receive Raltegravir 400 mg BID along with Truvada for 104 weeks.

Official Title
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CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Raltegravir + Truvada


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks | Drug: Raltegravir + Truvada<br>* Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks<br>* Other names: emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess Raltegravir tolerability, acceptability, and adherence among African-American men and women initiating HIV therapy. 2. Determine the pharmacokinetics of Raltegravir in African-American men and women. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the pharmacokinetics of Raltegravir in African-American men and women. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, African American, treatment naïve