A Safety and Pharmacokinetic Study for Dapivirine and Maraviroc Gel in Belgium

NCT01242579 | Withdrawn Phase 1 DMC

• 1 other identifier: IPM 025
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc gel and determine whether it is safe for daily use by healthy women in the United Kingdom

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• Safety: To assess the safety and tolerability of the combination maraviroc and dapivirine gel, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description).

  * Mucosal abnormalities (as defined in the WHO/CONRAD manual) visible during naked eye examination and/or colposcopy; * Abnormal vaginal pH and/or abnormal vaginal flora during the course of the trial; * Positive diagnostic tests for trichomonas, gonorrhoea and/or chlamydia; * At least one adverse event during the 2 month trial period; * Any laboratory abnormalities on haematology, electrolytes, liver function, and renal function.

  8 weeks

• Pharmacokinetics: assessment of local and systemic pharmacokinetics of maraviroc and dapivirine in plasma, vaginal fluid and cervical tissue before, during and after 11 days.

  8 weeks

Study Arms (4)

Maraviroc Vaginal Gel

ACTIVE COMPARATOR

Drug: Maraviroc dosage form: vaginal gel dosage: 2.5g frequency: once daily duration: 11 days

Drug: Maraviroc Vaginal Gel

Dapivirine Vaginal Gel

ACTIVE COMPARATOR

Drug: Dapivirine dosage form: vaginal gel dosage: 2.5g dapivirine frequency: once daily duration: 11 days

Drug: Dapivirine Vaginal Gel

Matching Placebo Gel

PLACEBO COMPARATOR

Drug: placebo dosage form: vaginal gel dosage: 2.5g placebo frequency: once daily duration: 11 days

Drug: Matching Placebo Gel

Maraviroc/Dapivirine Gel

EXPERIMENTAL

Drug: Maraviroc/Dapivirine dosage form: combination vaginal gel dosage: 2.5g - Maraviroc 0.1%, Dapivirine 0.05% frequency: once daily duration: 11 days

Drug: Maraviroc/Dapivirine Gel

Interventions

Maraviroc/Dapivirine Gel DRUG

Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05%

Maraviroc/Dapivirine Gel

Dapivirine Vaginal Gel DRUG

Dapivirine vaginal gel containing 2.5g

Dapivirine Vaginal Gel

Maraviroc Vaginal Gel DRUG

Maraviroc vaginal gel containing 2.5g

Maraviroc Vaginal Gel

Matching Placebo Gel DRUG

Matching placebo gel containing 2.5g

Matching Placebo Gel

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18 to40 years of age who can give written informed consent (illiterate participants may provide a thumbprint or mark witnessed and signed by a person independent from trial staff);
• Available for all visits and consent to follow all procedures scheduled for the trial;
• HIV-negative as determined by an HIV test at time of enrollment;
• Be on a stable form of contraception, defined as:
• A stable oral contraceptive regimen for at least 2 months prior to enrollment, OR,
• Transdermal contraceptive patch for at least 3 months prior to enrollment, OR,
• Long-acting progestins for at least 6 months prior to enrollment, OR,
• An IUD inserted (with no vaginal or gynaecological complaints associated with its use) at least 3 months prior to enrolment, OR,
• Have undergone surgical sterilization at least 3 months prior to enrollment;
• In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses;
• Upon pelvic examination and colposcopy at the time of enrollment, the cervix and vagina appear normal as determined by the Investigator;
• Asymptomatic for genital infections at the time of enrollment (if a woman is diagnosed with any treatable STI, either syndromically or by laboratory test at the time of screening, she must receive treatment at least 2 weeks prior to enrollment and have completed treatment);
• Willing to refrain from the use of vaginal products or objects including, tampons, female condoms, cotton wool, rags, diaphragms, cervical caps (or any other vaginal barrier method), douches, lubricants, vibrators/dildos, and drying agents for 14 days prior to enrollment and for the duration of the trial;
• Willing to use oral contraceptives to avoid menstruation, if necessary, while taking part in this trial;
• Documentation of no abnormality on Pap test, including grossly bloody smear, within 3 months prior to screening;

You may not qualify if:

• Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening;
• Currently breast-feeding;
• Currently or within two months of participation in any other clinical research trial involving investigational or marketed products prior to screening;
• Untreated symptomatic urogenital infections, e.g., urinary tract or other sexually transmitted infections, or other gynaecological conditions such as vaginal itching, pain, or discharge, within 2 weeks prior to enrolment;
• Presence of any abnormal clinically significant physical finding on the vulva, vaginal walls or cervix during pelvic examination and/or colposcopy at pre-enrolment;
• History of urogenital or uterine prolapse, undiagnosed vaginal bleeding, urethral obstruction, incontinence or urge incontinence;
• Current vulvar or vaginal symptoms/abnormalities that could influence the trial results;
• Pap test result that requires cryotherapy, biopsy, treatment (other than for infection); or further evaluation \[this includes any findings of atypical squamous cells of undetermined significance (ASCUS)\];
• Symptomatic genital HSV infection or a history of genital herpetic infection;
• Any Grade 2, 3 or 4 haematology, chemistry or urinalysis laboratory abnormality at baseline (screening) according to the DAIDS Table for Grading Adverse Events (NOTE: This table can be found at: http://rcc.tech-res.com/safetyandpharmacovigilance;and a standardized version will be provided to the research centre in the Study Operations Manual);
• Unexplained, abnormal bleeding per vagina during or following vaginal intercourse, or gynaecologic surgery within 90 days prior to enrollment;
• Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or silicone;
• Any serious acute, chronic or progressive disease (e.g., any known history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV, AIDS, or blood dyscrasias), or signs of cardiac disease, renal failure, or severe malnutrition;
• Have undergone a hysterectomy;
• History of drug abuse within 1 year of enrollment;

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Maraviroc

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)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 17, 2010
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 9, 2011

Record last verified: 2011-09