First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01719627 |
Recruitment Status
:
Completed
First Posted
: November 1, 2012
Last Update Posted
: March 5, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: Maraviroc Drug: TVD 300/200 QD | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
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
|
- Infectivity of HIV: p24 production [ Time Frame: Baseline ]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) ]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.
- Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
- Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ]
- Truvada plasmatic levels [ Time Frame: Visit 1 (day 7) ]
- Truvada levels in rectal mucosa [ Time Frame: Visit 1 (day 7) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men who have sex with men (MSM)
- Age 18 years or above
- HIV negative at the time of inclusion 4. Signed informed consent
Exclusion Criteria:
- Existence of sexually transmitted infection (STI) or active systemic infection
- Submit a contraindication to rectal biopsy
- Take any drugs concomitantly with interactions with the MVC
- Subject unable to follow protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719627
Spain | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 |
Responsible Party: | Fundacio Lluita Contra la SIDA |
ClinicalTrials.gov Identifier: | NCT01719627 History of Changes |
Other Study ID Numbers: |
MARAVIPREX |
First Posted: | November 1, 2012 Key Record Dates |
Last Update Posted: | March 5, 2015 |
Last Verified: | March 2015 |
Keywords provided by Fundacio Lluita Contra la SIDA:
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa. |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Maraviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |