AzTrials
AzTrials

HIV InfectionsPhase 1NCT00213005

Safety and Acceptability of Carraguard® in HIV Positive Women and Men

A Phase 1 study testing Carraguard (PC-515) in people with HIV Infections, run by Population Council at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
HIV Infections
What is being tested?
Carraguard (PC-515)
How many people
60 participants
Where
1 siteSouth Africa
Study dates
Jun 2002to Aug 2003
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Medical Research Council

    Durban

Other trials in South Africa

About this study

Official title: A Phase 1 Safety and Acceptability Study of Carraguard® Among HIV Positive Women and Men in Durban, South Africa

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.

Read the 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.

Conditions
HIV Infections
Being tested
Carraguard (PC-515)
Keywords
Microbicides, HIV prevention, HIV positive, carrageenan, safety trial, Treatment Experienced, HIV
Medical subject headings
HIV Infections, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carraguard (PC-515)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: genital findings, epithelial disruption, vaginal flora changes, genital shedding, inflammation & self-reported symptoms. Assessments were made weekly at days 7, 14 & 21.

  2. Acceptability: interviewer-administered questionnaires & daily diaries. Interviewer-administered questionnaires assessed at day 21 & daily diaries were assessed at days 14 and 21.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startJun 2002
  3. Study completionAug 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00213005
Sponsor's protocol ID
Population Council #297
Status last verified
Aug 2017
First submitted
13 Sep 2005
Last updated
14 Aug 2017
Results posted
No

Publications

  • 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.

    PubMed 18193495

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carraguard (PC-515) in people with HIV Infections, run by Population Council at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: genital findings, epithelial disruption, vaginal flora changes, genital shedding, inflammation & self-reported symptoms. Assessments were made weekly at days 7, 14 & 21.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00213005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in