NCT00213005

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Jun 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

First QC Date

September 13, 2005

Last Update Submit

August 11, 2017

Conditions

HIV Infections

Keywords

MicrobicidesHIV preventionHIV positivecarrageenansafety trialTreatment ExperiencedHIV

Outcome Measures

Primary Outcomes (2)

  • 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.

Interventions

Carraguard (PC-515)DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Council

Durban, South Africa

Location

Related Publications (1)

  • 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. doi: 10.1097/qai.0b013e318159d5a8.

    PMID: 18193495DERIVED

MeSH Terms

Conditions

HIV InfectionsHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Janneke van de Wijgert, Ph.D.

    International Antiviral Therapy Evaluation Center

    PRINCIPAL INVESTIGATOR

  • Gita Ramjee, Ph.D

    Medical Research Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2002

Study Completion

August 1, 2003

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

ZA(1)