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

NCT00667433 | Completed Phase 1

• 1 other identifier: CID 0706
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV; African American; treatment naïve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine the pharmacokinetics of Raltegravir in African-American men and women.

  2 years

Study Arms (1)

Single Arm

OTHER

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

Drug: Raltegravir + Truvada

Interventions

Raltegravir + Truvada DRUG

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

Also known as: MK-0518; Isentress, emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• David A Wohl, MD: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7215, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• 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.

  PMID: 17721395 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine; Tenofovir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Study Officials

• David A Wohl, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 28, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

US (2)