First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers

This study has suspended participant recruitment.
(Depending on results, study will be resumed or terminated)
Sponsor:
Information provided by (Responsible Party):
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier:
NCT01719627
First received: October 10, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential of MVC as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of HIV infection in men who have sex with men (MSM).


Condition Intervention Phase
HIV
Drug: Maraviroc
Drug: TVD 300/200 QD
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC

Resource links provided by NLM:


Further study details as provided by Fundacio Lluita Contra la SIDA:

Primary Outcome Measures:
  • Infectivity of HIV: p24 production [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.

  • Infectivity of HIV: p24 production [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
    HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.


Secondary Outcome Measures:
  • Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
  • Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: October 2012
Estimated Study Completion Date: January 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MVC 300 mg
MVC 300 mg in unique dose
Drug: Maraviroc
Unique dose of Maraviroc 300mg
Active Comparator: TVD 300/200 QD
TVD 300/200 QD during 7 days.
Drug: TVD 300/200 QD
TVD 300/200 QD during 7 days
Experimental: Maraviroc 600mg
MVC 600mg in unique dose
Drug: Maraviroc
Unique dose of Maraviroc 600mg

Detailed Description:

Several clinical trials are currently under way evaluating the safety and effectiveness of ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs compared to those receiving placebo. Although the results are promising, concerns about adherence, pharmacokinetics, and toxicity still needs further exploration so new and more effective preventive pharmacological approaches should be evaluated. This trial will evaluate the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study visits will include a physical examination, blood collection and storage and in the basal visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men who have sex with men (MSM)
  2. Age 18 years or above
  3. HIV negative at the time of inclusion 4. Signed informed consent

Exclusion Criteria:

  1. Existence of sexually transmitted infection (STI) or active systemic infection
  2. Submit a contraindication to rectal biopsy
  3. Take any drugs concomitantly with interactions with the MVC
  4. Subject unable to follow protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719627

Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Fundacio Lluita Contra la SIDA
  More Information

No publications provided

Responsible Party: Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier: NCT01719627     History of Changes
Other Study ID Numbers: MARAVIPREX
Study First Received: October 10, 2012
Last Updated: September 9, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Fundacio Lluita Contra la SIDA:
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014