## Protocol Section
### Identification Module
**NCT ID:** NCT03044379

**Brief Title:** Dapivirine Gel Rectal Safety and PK Study

**Official Title:** A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

#### Organization Study ID Info
**ID:** MTN-026/ IPM 038
#### Organization
**Class:** INDUSTRY
**Full Name:** International Partnership for Microbicides, Inc.
### Status Module
#### Completion Date
**Date:** 2017-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-02-06

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2017-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2015-09-29

**Type:** ACTUAL

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2017-02-07
**Type:** ESTIMATED
**Study First Submit Date:** 2016-09-06
**Study First Submit QC Date:** 2017-02-02
**Why Stopped:** Current program is on hold, not for safety reason
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** International Partnership for Microbicides, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Dapivirine Gel Rectal Safety and PK Study

**Detailed Description:** A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

### Conditions Module

**Conditions:**

- HIV 1 Infection

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will be randomized to receive a single dose of dapivirine gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.

**Intervention Names:**

- Drug: Dapivirine gel (0.05%)

**Label:** Dapivirine Gel

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Participants will be randomized to receive the universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.

**Intervention Names:**

- Other: Universal HEC placebo gel

**Label:** Placebo Gel HEC

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dapivirine Gel

**Description:** MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.

**Name:** Dapivirine gel (0.05%)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo Gel HEC

**Name:** Universal HEC placebo gel

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the safety of dapivirine gel formulation when applied rectally.

**Measure:** Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.

**Time Frame:** 9-12 months

#### Secondary Outcomes

**Description:** To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.

**Measure:** Acceptability

**Time Frame:** 9-12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age of 18 - 45 years (inclusive), verified per site SOP
* Able and willing to provide written informed consent
* HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results
* Able and willing to provide adequate locator information, as defined in site SOP
* Available to return for all study visits and willing to comply with study participation requirements
* In general good health at Screening and Enrollment, as determined by the site IoR or designee
* Per participant report, a history of consensual RAI at least once in the past calendar year
* Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment

Exclusion Criteria: At Screening:

* Hemoglobin Grade 1 or higher\*
* Platelet count Grade 1 or higher\*
* White blood count Grade 2 or higher\*
* Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
* International normalized ratio (INR) 1.5 the site laboratory ULN
* Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher\*
* Positive for hepatitis C antibody
* Positive for hepatitis B surface antigen
* History of inflammatory bowel disease by participant report

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pittsburgh

**Country:** United States

**Facility:** University of Pittsburgh Medical Center

**State:** Pennsylvania

**Zip:** 15213

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000019380

- Term: Anti-HIV Agents

- ID: D000044966

- Term: Anti-Retroviral Agents

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M256068

- Name: Dapivirine

- Relevance: HIGH

- As Found: Adult acute lymphoblastic leukemia

- ID: M21350

- Name: Anti-HIV Agents

- Relevance: LOW

- As Found: Unknown

- ID: M25428

- Name: Anti-Retroviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000481671

- Term: Dapivirine

### Misc Info Module

- Version Holder: 2024-05-24
