Condition category
Infections and Infestations
Date applied
03/06/2005
Date assigned
08/07/2005
Last edited
09/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lut Van Damme

ORCID ID

Contact details

1611 N Kent Street
Suite 806
Arlington
VA
22209
United States of America
+1 703 276 4020
lvandamme@conrad.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00153777

Protocol/serial number

C03-090

Study information

Scientific title

Acronym

Study hypothesis

Effect on vaginal male-to-female transmission of HIV/Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT). Null hypotheses (of no effect) are tested.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

International

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

HIV infection

Intervention

Randomized to 6% CS gel or Placebo gel; both arms receive condoms and safer sex counseling. Any curable sexually transmitted infection (STI) or urinary tract infection (UTI) will be treated. Referrals for other conditions. Three monthly gynecological exam with STI testing.

Intervention type

Drug

Phase

Phase III

Drug names

Cellulose sulfate

Primary outcome measures

HIV infection (incident)

Secondary outcome measures

NG infection; CT infection

Overall trial start date

13/06/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy women at risk of HIV infection through their own sexual behavior.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2574

Participant exclusion criteria

HIV positive women or at risk of HIV through other transmission routes; pregnant women.

Recruitment start date

13/06/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

Benin, Burkina Faso, India, South Africa, Uganda

Trial participating centre

1611 N Kent Street
Arlington, VA
22209
United States of America

Sponsor information

Organisation

CONRAD (USA)

Sponsor details

1611 N Kent Street
Suite 806
Arlington
VA
22209
United States of America
+1 703 524 4744
lvandamme@conrad.org

Sponsor type

Government

Website

http://www.conrad.org

Funders

Funder type

Government

Funder name

US Agency for International Development (USAID): $12M

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bill and Melinda Gates Foundation (USA): $12M

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18669425
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21048963

Publication citations

  1. Results

    Crucitti T, Fransen K, Maharaj R, Tenywa T, Massinga Loembé M, Murugavel KG, Mendonca K, Abdellati S, Beelaert G, Van Damme L, Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial., PLoS ONE, 2010, 5, 10, e13592, doi: 10.1371/journal.pone.0013592.

  2. Van Damme L, Govinden R, Mirembe FM, Guédou F, Solomon S, Becker ML, Pradeep BS, Krishnan AK, Alary M, Pande B, Ramjee G, Deese J, Crucitti T, Taylor D, , Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission., N. Engl. J. Med., 2008, 359, 5, 463-472, doi: 10.1056/NEJMoa0707957.

Additional files

Editorial Notes