March 13, 2012
www.conrad.org
 

CONRAD News

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19th Conference on Retroviruses and Opportunistic Infections: Presentation Highlights

MTN presented results of the MTN-007 study, a Phase I trial of a rectal formulation of tenofovir gel.  The study found that the reduced glycerin version of the gel was safe and acceptable to use in HIV negative men and women who used it once a day for a week.  Study participants were randomly assigned to one of four study groups, one used the reformulated tenofovir gel, one group used a placebo and the third nonoxynol 9. A fourth group used no gel but participated in study-related procedures and tests. Study results indicated no significant differences in side effects among the gel groups and adherence was high, with 94 percent using the products daily as directed.  The Phase II trial, MTN-017, is slated to begin later this year at sites in South Africa, Thailand, Peru and the U.S.

FEM-PrEP results were presented by FHI's Dr. Lut Van Damme, who concluded that inadequate adherence undermined the trial’s ability to fully assess the effectiveness of Truvada as PrEP in this particular population of women. According to Dr. Van Damme, the adherence rate from pill counts was 86 percent in the Truvada group and 89 percent in the placebo group, yet blood levels in these groups indicated a much lower level of drug use.   Factors that may have contributed to adherence were the younger ages of the participants, and their belief that they were not at risk for contracting HIV, despite the high level of counseling they received.  The reasons for the disparity between the pill counts and blood levels has not been determined.

Congratulations to Slim and Quarrisha Abdool Karim for winning this year's N'galy-Mann award at CROI.The N’Galy-Mann Lectureship was established to recognize an AIDS researcher who has made important and timely contributions in epidemiology and/or clinical research as exemplified by the collaborative careers of Bosenge N’Galy and Jonathan Mann.

Woman's Condom

The Woman’s Condom, developed by PATH and CONRAD, has been selected as one of the 50 most inspiring ideas and solutions for women.

The Women Deliver 50 competition is sponsored by Women Deliver, a global advocacy organization with a mission to improve the health and well being for girls and women around the world. Each year in conjunction with International Women’s Day, March 8, Women Deliver celebrates the progress made on behalf of girls and women.

CONRAD's work with female condoms helped lead to the 1993 FDA approval of the first female condom on the U. S. market, the FC Female Condom. Since 1998, CONRAD has supported PATH in the development of the Woman’s Condom.  CONRAD collaborated with the California Family Health Council on a study that compared the performance of the Woman’s Condom and the FC2 Female Condom by using self reporting as well as vaginal detection of prostate-specific antigen (PSA) as an indicator of condom failure. In parallel, the National Institute of Child Health and Human Development (NICHD) Contraceptive Clinical Trials Network performed a Phase III contraceptive efficacy study of the Woman’s Condom.

FDA and Tenofovir Gel

CONRAD continues to spearhead regulatory efforts for tenofovir gel and recently held a meeting with the FDA, donors and the FACTS team to review FACTS 001 and 002 protocols as well as CONRAD's tenofovir clinical program.  FACTS 001 is a Phase III efficacy trial of tenofovir gel that is currently enrolling participants at nine sites in South Africa. FACTS 002 is a safety study that will test tenofovir gel in young women 16-17 years old. FDA agreed that the FACTS 001 study can be considered as a confirmatory trial for HIV prevention indication for tenofovir gel.  The South African FACTS 001 protocol team is revising the current protocol to address a few FDA comments.

Publications

Drs. Meredith Clark and David Friend recently published in AIDS Research and Human Retroviruses.  The abstract, Pharmacokinetics and Topical Vaginal Effects of Two Tenofovir Gels in Rabbits, can be read in full here.

Product Development Updates

Since the success of the CAPRISA 004 trial, CONRAD has shifted significant attention to developing and testing tenofovir gel for vaginal and rectal use for the prevention of HIV and HSV-2. CONRAD is also developing new formulations of tenofovir including fast-dissolve tablets and an intravaginal ring. To that end, our preclinical, clinical and product development teams are working on a number of studies, detailed in the table below, in addition to supplying tenofovir gel to FACTS 001 and 002, the Microbicide Trials Network, and other tenofovir studies currently in the field.  

As a reproductive health research organization, CONRAD continues to develop new methods of contraception, including the PATH SILCS diaphragm, the PATH Woman's Condom, Cyclofem (a monthly injectable for women), meloxicam (a nonhormonal daily pill for women), and LNG butanoate (an injectable for women).

 CONRAD Clinical Studies: Active, Phase 1

Title and Protocol #

Summary

Site(s)

Status

CONRAD 113

Pharmacokinetics (PK)/Pharmacodynamics (PD) Study of Tenofovir (TFV) Gel

Assessing local (vaginal) and systemic (blood) levels of TFV with different gel dosing regimens: before and after sex, before sex, after sex, and daily

Eastern Virginia Medical School (EVMS)

PROFAMILIA

University of Pittsburgh

Advances in Health

University of Pennsylvania

Currently enrolling participants

 

CONRAD Clinical Studies: Pending,  Phase 1

Title and Protocol #

Summary

Site(s)

Status

CONRAD 114

Effects of Contraception and Menstrual Cycle on PK/PD and Vaginal Safety in TFV Gel Users

Effects of Depo-Provera, oral contraceptives and the menstrual cycle on PK/PD and safety of TFV gel

EVMS

PROFAMILIA

University of Pittsburgh

Protocol in development

Start: Q1 2012

CONRAD 118

PK Study of TFV Gel with Three Commonly Used Vaginal Products

Interaction of TFV gel and antifungal cream, antimicrobial gel and contraceptive ring

University of California, San Francisco

Bronx-Lebanon Hospital

Protocol in development

Start: pending, target Q2 2012

CONRAD 117

PK/PD and Safety Study of TFV/FTC Vaginal Tablet

Assessing safety, PK/PD and acceptability of the combination TFV/FTC vaginal tablet

EVMS

TBD

Protocol in development

Start: pending, target Q2 2012

CONRAD 120

PK/PD and Safety Study of TFV Intravaginal Ring (IVR)

Assessing safety and PK/PD of TFV IVR

EVMS

Albert Einstein College of Medicine

Protocol in development

Start: pending, target Q4 2012

CONRAD 121

PK/PD and Safety Study of TFV/Levonorgestrel (LNG) IVR

Assessing safety and PK/PD of TFV/LNG IVR

EVMS

TBD

Protocol in development

Start: pending, target Q4 2012

CONRAD 122

Postcoital Testing of TFV Gel/SILCS Diaphragm

Assessing ability of TFV gel/SILCS diaphragm to prevent sperm from penetrating cervical mucous

EVMS

Protocol in development

Start: target 2013

CONRAD 123

PK/PD and Safety Study of TFV Gel/SILCS Diaphragm

Assessing safety and PK/PD of TFV gel/SILCS diaphragm

TBD

Protocol in development

Start: target 2013