ClinicalTrials.gg
Sign In
CompletedNCT00774683Updated Oct 25, 2011

A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women

An observational study in HIV and AIDS, sponsored by Kristine Patterson, MD. Completed at 1 site in United States. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2011-10-25.

Sponsored by Kristine Patterson, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 49 Years
Sex
Female
01

Study summary

The purpose of this research sub-study is to learn about the levels of an antiretroviral (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of HIV-positive women.

We would like to see how this study medication is tolerated, and how the body processes the study medication in women who are HIV-positive. More specifically, we are interested in how Isentress® might penetrate into the female cervicovaginal secretions thereby potentially reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital secretions may prevent female subjects from transmitting HIV to their sexual partners. This information will help the research team know how a medication such as Isentress® might be used to prevent the sexual transmission of HIV.

Read the detailed description

Purpose: This study aims to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma pharmacokinetics being obtained in the main study, CID 0706.

Participants: Six HIV-positive women from the CID 0706 study Procedures: During the pharmacokinetic visit to obtain blood plasma in the CID 0706 study, women will be asked to self-collect cervicovaginal samples using a vaginal aspirator at the following timepoints: pre-dose and 1, 2, 4, 6, 8, and 12 hours after raltegravir 400mg dose administration.

02

Conditions studied

  • HIV
  • AIDS

Keywords

  • Pilot
  • Pharmacokinetics
  • Raltegravir
  • Cervicovaginal
  • HIV
  • Women
03

In context

Acquired Immunodeficiency Syndrome

2,102 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 277 are open to participants now.

This study's enrollment of 1 is below the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Kristine Patterson, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

UNC ID Clinic, Durham County Health Department, Wake County Health Department

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 > 60 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).

Exclusion criteria

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
  • A positive test for bacterial vaginosis, syphilis, gonorrhea, Chlamydia, HSV-2 (active lesions), or trichomonas at entry or week 2 of the main study, CID 0706
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Sub-study Group A

    Six HIV-positive African American women from the main study, CID 0706

    Drug: Raltegravir (Isentress®)

Interventions

06

What researchers measure

Primary outcomes

  1. To characterize the pharmacokinetics of raltegravir in cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma pharmacokinetics being obtained in the main study, CID 0706.

    Time frame: Single Time Point Measurement at 4 Weeks after ART Initiation

07

Study locations

1 site
  • The University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27514, United States
08

References and documents

Publications

  • Musicco M, Lazzarin A, Nicolosi A, Gasparini M, Costigliola P, Arici C, Saracco A. Antiretroviral treatment of men infected with human immunodeficiency virus type 1 reduces the incidence of heterosexual transmission. Italian Study Group on HIV Heterosexual Transmission. Arch Intern Med. 1994 Sep 12;154(17):1971-6. PubMed 8074601 ↗
  • Otten RA, Smith DK, Adams DR, Pullium JK, Jackson E, Kim CN, Jaffe H, Janssen R, Butera S, Folks TM. Efficacy of postexposure prophylaxis after intravaginal exposure of pig-tailed macaques to a human-derived retrovirus (human immunodeficiency virus type 2). J Virol. 2000 Oct;74(20):9771-5. doi: 10.1128/jvi.74.20.9771-9775.2000. PubMed 11000253 ↗
  • Lallemant M, Jourdain G, Le Coeur S, Mary JY, Ngo-Giang-Huong N, Koetsawang S, Kanshana S, McIntosh K, Thaineua V; Perinatal HIV Prevention Trial (Thailand) Investigators. Single-dose perinatal nevirapine plus standard zidovudine to prevent mother-to-child transmission of HIV-1 in Thailand. N Engl J Med. 2004 Jul 15;351(3):217-28. doi: 10.1056/NEJMoa033500. Epub 2004 Jul 9. PubMed 15247338 ↗
  • Blankson JN, Persaud D, Siliciano RF. The challenge of viral reservoirs in HIV-1 infection. Annu Rev Med. 2002;53:557-93. doi: 10.1146/annurev.med.53.082901.104024. PubMed 11818490 ↗
  • Pierson T, Hoffman TL, Blankson J, Finzi D, Chadwick K, Margolick JB, Buck C, Siliciano JD, Doms RW, Siliciano RF. Characterization of chemokine receptor utilization of viruses in the latent reservoir for human immunodeficiency virus type 1. J Virol. 2000 Sep;74(17):7824-33. doi: 10.1128/jvi.74.17.7824-7833.2000. PubMed 10933689 ↗
  • Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956. PubMed 17133211 ↗
  • Cohen MS. Preventing sexual transmission of HIV. Clin Infect Dis. 2007 Dec 15;45 Suppl 4:S287-92. doi: 10.1086/522552. PubMed 18190301 ↗
  • Isentress (Raltegravir) Prescribing Guide. Merck & Co., Inc. October 2007
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00774683
Lead sponsor
Kristine Patterson, MD
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Kristine Patterson, MD (Clinical Associate Professor, University of North Carolina, Chapel Hill) — Sponsor-investigator
First posted
Oct 17, 2008
Start date
Aug 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Oct 25, 2011

Study contacts

Kristine B Patterson, MD
principal investigator · University of North Carolina, Chapel Hill
Angela DM Kashuba, PharmD
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acquired Immunodeficiency Syndrome →

Other studies from this sponsor

Kristine Patterson, MD

Start the discussion