NCT00153777

Brief Summary

The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route. The study hypothesis is that there will be no effect.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
1,428

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2005

Geographic Reach
4 countries

5 active sites

Status
terminated

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

First QC Date

September 8, 2005

Last Update Submit

August 27, 2015

Conditions

HIV Infection

Keywords

HIV preventionRandomized controlled trialWomenSexually transmitted infectionsHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Combined incidence of HIV-1 and HIV-2 in the study.

    1 year

Secondary Outcomes (1)

  • Time-to-first incidental gonococcal or chlamydial infection.

    1 year

Interventions

Cellulose Sulfate gel (6%)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years old
  • an average of at least three vaginal sex acts per week, at least three different partners in the last three months, expecting to continue this behavior
  • HIV negative
  • willing and able to comply with the protocol

You may not qualify if:

  • pregnancy
  • allergy to latex or spermicides
  • intravenous drug user

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Projet SIDA3

Cotonou, Benin

Location

Karnataka Health Promotion Trust

Bangalore, India

Location

YRG Care

Chennai, India

Location

Medical Research Council

Durban, South Africa

Location

Makarere University - Mulago Hospital

Kampala, Uganda

Location

Related Publications (10)

  • Crucitti T, Jespers V, Van Damme L, Van Dyck E, Buve A. Vaginal microbicides can interfere with nucleic acid amplification tests used for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infection. Diagn Microbiol Infect Dis. 2007 Jan;57(1):97-9. doi: 10.1016/j.diagmicrobio.2006.05.010. Epub 2006 Jul 21.

    PMID: 16860515BACKGROUND

  • Schwartz JL, Mauck C, Lai JJ, Creinin MD, Brache V, Ballagh SA, Weiner DH, Hillier SL, Fichorova RN, Callahan M. Fourteen-day safety and acceptability study of 6% cellulose sulfate gel: a randomized double-blind Phase I safety study. Contraception. 2006 Aug;74(2):133-40. doi: 10.1016/j.contraception.2006.02.008. Epub 2006 May 2.

    PMID: 16860051BACKGROUND

  • El-Sadr WM, Mayer KH, Maslankowski L, Hoesley C, Justman J, Gai F, Mauck C, Absalon J, Morrow K, Masse B, Soto-Torres L, Kwiecien A. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS. 2006 May 12;20(8):1109-16. doi: 10.1097/01.aids.0000226950.72223.5f.

    PMID: 16691061BACKGROUND

  • Malonza IM, Mirembe F, Nakabiito C, Odusoga LO, Osinupebi OA, Hazari K, Chitlange S, Ali MM, Callahan M, Van Damme L. Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel. AIDS. 2005 Dec 2;19(18):2157-63. doi: 10.1097/01.aids.0000194797.59046.8f.

    PMID: 16284466BACKGROUND

  • Mauck C, Weiner DH, Ballagh S, Creinin M, Archer DF, Schwartz J, Pymar H, Lai JJ, Callahan M. Single and multiple exposure tolerance study of cellulose sulfate gel: a Phase I safety and colposcopy study. Contraception. 2001 Dec;64(6):383-91. doi: 10.1016/s0010-7824(01)00271-2.

    PMID: 11834238BACKGROUND

  • Mauck C, Frezieres R, Walsh T, Robergeau K, Callahan M. Cellulose sulfate: tolerance and acceptability of penile application. Contraception. 2001 Dec;64(6):377-81. doi: 10.1016/s0010-7824(01)00270-0.

    PMID: 11834237BACKGROUND

  • Anderson RA, Feathergill KA, Diao XH, Cooper MD, Kirkpatrick R, Herold BC, Doncel GF, Chany CJ, Waller DP, Rencher WF, Zaneveld LJ. Preclinical evaluation of sodium cellulose sulfate (Ushercell) as a contraceptive antimicrobial agent. J Androl. 2002 May-Jun;23(3):426-38.

    PMID: 12002445BACKGROUND

  • Guedou FA, Van Damme L, Deese J, Crucitti T, Becker M, Mirembe F, Solomon S, Alary M. Behavioural and medical predictors of bacterial vaginosis recurrence among female sex workers: longitudinal analysis from a randomized controlled trial. BMC Infect Dis. 2013 May 8;13:208. doi: 10.1186/1471-2334-13-208.

    PMID: 23657072DERIVED

  • Crucitti T, Fransen K, Maharaj R, Tenywa T, Massinga Loembe 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 Oct 27;5(10):e13592. doi: 10.1371/journal.pone.0013592.

    PMID: 21048963DERIVED

  • Van Damme L, Govinden R, Mirembe FM, Guedou F, Solomon S, Becker ML, Pradeep BS, Krishnan AK, Alary M, Pande B, Ramjee G, Deese J, Crucitti T, Taylor D; CS Study Group. Lack of effectiveness of cellulose sulfate gel for the prevention of vaginal HIV transmission. N Engl J Med. 2008 Jul 31;359(5):463-72. doi: 10.1056/NEJMoa0707957.

    PMID: 18669425DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lut Van Damme, MD, MSc, PhD

    CONRAD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

July 1, 2005

Study Completion

March 1, 2007

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

ZA(1)UG(1)IN(2)BE(1)