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

NCT ID: NCT00667433

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2011-12-31

Brief 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.

Detailed Description

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.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks

Group Type: OTHER

Raltegravir + Truvada

Intervention Type: DRUG

Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks

Interventions

Raltegravir + Truvada

Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks

Intervention Type: DRUG

Other Intervention Names

MK-0518; Isentress; emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

David A Wohl, MD

OTHER

Sponsor Role: lead

Responsible Party

David A Wohl, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David A Wohl, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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

Countries

United States

References

Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.

Reference Type: BACKGROUND

PMID: 17721395 (View on PubMed)

Other Identifiers

CID 0706

Identifier Type: -

Identifier Source: org_study_id