Safety and Acceptability of Carraguard® in HIV Positive Women and Men - Full Text View

Sponsors and Collaborators:	Population Council Centers for Disease Control and Prevention Medical Research Council
Information provided by:	Population Council
ClinicalTrials.gov Identifier:	NCT00213005

Purpose

The study objectives were to assess the mucosal safety of Carraguard® gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported by female and male participants during the study may be related to the use of Carraguard® gel; and to examine dimensions of the acceptability of, and compliance with, the study and placebo products.

Condition	Intervention	Phase
HIV Infections	Drug: Carraguard (PC-515)	Phase I

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase 1 Safety and Acceptability Study of Carraguard® Among HIV Positive Women and Men in Durban, South Africa

Further study details as provided by Population Council:

Primary Outcome Measures:

Safety: genital findings, epithelial disruption, vaginal flora changes, genital shedding, inflammation & self-reported symptoms. Assessments were made weekly at days 7, 14 & 21.
Acceptability: interviewer-administered questionnaires & daily diaries. Interviewer-administered questionnaires assessed at day 21 & daily diaries were assessed at days 14 and 21.

Estimated Enrollment:	60
Study Start Date:	June 2002
Estimated Study Completion Date:	August 2003

Detailed Description:

We proposed a safety study of the Council’s lead candidate microbicide, Carraguard® in three cohorts in Durban, South Africa: sexually abstinent HIV-positive women, sexually abstinent HIV-positive men, and sexually active HIV-positive women. Sexually active women must be in an HIV-positive seroconcordant relationship (confirmed by HIV testing of the woman and her male partner) and written informed consent was obtained from the male partners. Women and men in each cohort were randomized to one of three study groups: Carraguard® gel, its matching placebo methyl-cellulose gel, or no product.

The main objectives of this study were to investigate changes in the vulvar, vaginal, and cervical epithelia, the vaginal flora, and HIV-1 shedding in the genital tract of female participants, and changes of the penile skin and epithelia of male participants. We also evaluated symptoms reported by participants, and several dimensions of the acceptability of and compliance with the study or placebo gel. Reactions to a non-contraceptive microbicide were assessed, as well as reasons for voluntary discontinuation and non-use of Carraguard® or the placebo (determined by review of daily diary) was recorded. Exit focus group discussions were held with male and female participants to discuss aspects of acceptability and compliance. Self-reported symptoms were also investigated by clinical examination as needed and study endpoints included genital itching or burning, frequent urination, burning while urinating, genital pain, pain during sex, and abnormal vaginal or penile discharge.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Positive for HIV-1 by licensed HIV test (with confirmation) and agree to be informed of the test result
Age 18 to 45 years old, for women (no maximum age for men)
In good health, defined as CD4+ cell count >200 x 106/L and current absence of opportunistic infections that may interfere with protocol adherence
If on treatment for HIV infection (including immune-boosters such as Moducare and vitamins): treatment should stay constant for the duration of the study
For sexually abstinent cohort: Willing to abstain from sexual intercourse and masturbation for the duration of the study (3 weeks) and for the 48 hours before joining the study
For sexually active cohort: Willing to have sex with only one male partner, and male partner is willing to have sex with only the participant, for the duration of the study
Regular menstrual cycle (3-5 weeks between periods) or amenorrheic due to long-term (three months or more) DMPA use (and have had no DMPA-related side effects that could interfere with study participation in the last 6 months)
Planning on living in Durban for the next 6 months
Willing to refrain from using any other vaginal products for the duration of the study (3 weeks), including other spermicides, diaphragm/cervical cap, traditional drying and tightening agents, douches, tampons, and medicinal products
Willing and able to comply with all other aspects of the study protocol, including clinical evaluations and study gel administration (if applicable)
Willing and able to give informed consent.

Exclusion Criteria:

Currently pregnant, menopausal or lactating, or desire to become pregnant at the time of study participation
Current or recent participation (within past 30 days) in any other clinical trial, including trials of HIV therapeutics and trials of vaginal products (this does not include the ongoing study in the Department of Paediatrics of King Edward VIII Hospital)
Delivery, miscarriage or abortion within the last six weeks
Gynecological surgery or instrumentation in the last three months
History of non-menstrual vaginal bleeding with intercourse in the last month
Presence of a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perianal ulcer and/or lesion) on which the epithelium is currently disrupted or is likely to disrupt (e.g. herpes blister). Women with healed/dried-up lesions from a past infection, or with a lesion on which the epithelium is currently intact or unlikely to disrupt, will be eligible for enrollment.
Presence of a sexually transmitted infection (STI), symptomatic yeast infection, or bacterial vaginosis (BV), as diagnosed by clinical exam or laboratory testing at screening. Women with asymptomatic yeast infection or BV may be enrolled.
Abnormal Pap smear (CIN I or higher) at screening
Use of any spermicide or spermicidally lubricated condom within the week prior to enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213005

Locations

South Africa
Medical Research Council
Durban, South Africa

Sponsors and Collaborators

Population Council

Centers for Disease Control and Prevention

Medical Research Council

Investigators

Principal Investigator:	Janneke van de Wijgert, Ph.D.	International Antiviral Therapy Evaluation Center
Principal Investigator:	Gita Ramjee, Ph.D	Medical Research Council

More Information

No publications provided by Population Council

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

van de Wijgert JH, Braunstein SL, Morar NS, Jones HE, Madurai L, Strickfaden TT, Moodley M, Aboobaker J, Ndlovu G, Ferguson TM, Friedland BA, Hart CE, Ramjee G. Carraguard Vaginal Gel Safety in HIV-Positive Women and Men in South Africa. J Acquir Immune Defic Syndr. 2007 Dec 15;46(5):538-46.

Study ID Numbers:	Population Council #297
Study First Received:	September 13, 2005
Last Updated:	December 21, 2005
ClinicalTrials.gov Identifier:	NCT00213005 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Population Council:

Microbicides
HIV prevention
HIV positive
carrageenan

safety trial
Treatment Experienced
HIV

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Seropositivity
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Immunologic Deficiency Syndromes

Virus Diseases
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009