NCT00262106

Brief Summary

The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
9,404

participants targeted

Target at P75+ for phase_3 hiv-infections

Timeline
Completed

Started Oct 2005

Typical duration for phase_3 hiv-infections

Geographic Reach
3 countries

5 active sites

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

October 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

December 5, 2005

Last Update Submit

September 5, 2012

Conditions

HIV InfectionsGonorrheaChlamydial InfectionsGenital Herpes

Keywords

Administration, intravaginalAnti-infective agentsDouble blind methodDrug evaluationFemaleGelsHIV infections/prevention and controlMicrobicideNaphthalenesulfonates/administration and dosagePolymers/administration and dosageSexual behaviorVaginal creams, foams and jelliesHIV SeronegativityGenital Herpes Infections

Outcome Measures

Primary Outcomes (2)

  • Acquisition of HIV infection before or at the 12 month time point, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment

    12 months

  • Grade 3 (severe) or 4 (life-threatening) clinical or laboratory adverse event confirmed on examination or repeat testing, respectively

    12 months

Secondary Outcomes (5)

  • Acquisition of HIV infection before or at the 6, 9, or beyond 12 month time points, confirmed in a central laboratory, in participants confirmed to be HIV negative at enrollment

    6, 9 and 12 months

  • HSV-2 incidence rates by the 9 month time point in participants uninfected at enrollment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high

    9 months

  • HSV-2 incidence rates by the 12 month time point in participants uninfected at enrolment. Although prevalence rates are high, 75% - 85% in some sites, data from feasibility studies indicate that incidence rates are also likely to be high

    12 months

  • Cross-sectional prevalence of Neisseria gonorrhoeae at 24 weeks, determined by a positive nucleic acid amplification assay

    24 weeks/6 months

  • Cross-sectional prevalence of Chlamydia trachomatis at 24 weeks, determined by a positive nucleic acid amplification assay

    24 wks/6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

PRO 2000/5 Gel 0.5%

ACTIVE COMPARATOR

PRO 2000/5 Gel 0.5%

Drug: PRO 2000/5

Interventions

PRO 2000/5DRUG

Gel

PRO 2000/5 Gel 0.5%
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 16 years and above at enrolment in Masaka and Mwanza, or aged 18 years and above at enrolment in the South African and Zambian sites
  • Likely to be sexually active at entry and during follow-up
  • Willing to undergo HIV testing at screening and approximately 12 weekly intervals, and additionally, if required, to determine HIV status
  • HIV negative at screening according to the local HIV testing algorithm
  • Willing to receive the HIV result before randomization
  • Willing to use study gel as instructed
  • Willing to undergo regular speculum examinations and genital infection screens
  • Willing to have regular urine pregnancy tests
  • Willing to receive health education about condoms
  • Willing and able to give informed consent

You may not qualify if:

  • Unable or unwilling to provide a reliable method of contact for the field team
  • Likely to move permanently out of the area within the next year
  • Likely to have sex more than 14 times a week on a regular basis during the course of follow-up
  • Using spermicides regularly
  • Pregnant or within 6 weeks postpartum at enrollment
  • Has Grade 3 clinical or laboratory abnormalities which are considered by the clinician or the Trial Management Group to make enrollment inadvisable
  • Requires referral for assessment of a clinically suspicious cervical lesion
  • Treatment to the cervix, or to the womb through the cervix, within 30 days of enrolment
  • Known latex allergy
  • Participating, or has participated within 30 days of enrolment, in a clinical trial of an unlicensed product, microbicide, barrier method, or any other intervention likely to impact on the outcome of this trial
  • Considered unlikely to be able to comply with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Reproductive Health and HIV Research Unit, Chris Hani Baragwanath Hospital

Bertsham, 2013, South Africa

Location

Africa Centre for Health and Population Studies

Mtubatuba, 3935, South Africa

Location

HIV Prevention Research Unit, Medical Research Council

Westville, 3630, South Africa

Location

AMREF Lake Zone Programme

Mwanza, Tanzania

Location

MRC Programme on AIDS in Uganda, Uganda Virus Research Institute

Entebbe, Uganda

Location

MDP Zambia, Nakambala Sugar Estate

Mazabuka, Zambia

Location

Related Publications (4)

  • Van Damme L, Wright A, Depraetere K, Rosenstein I, Vandersmissen V, Poulter L, McKinlay M, Van Dyck E, Weber J, Profy A, Laga M, Kitchen V. A phase I study of a novel potential intravaginal microbicide, PRO 2000, in healthy sexually inactive women. Sex Transm Infect. 2000 Apr;76(2):126-30. doi: 10.1136/sti.76.2.126.

    PMID: 10858715BACKGROUND

  • Mayer KH, Karim SA, Kelly C, Maslankowski L, Rees H, Profy AT, Day J, Welch J, Rosenberg Z; HIV Prevention Trials Network (HPTN) 020 Protocol Team. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS. 2003 Feb 14;17(3):321-9. doi: 10.1097/00002030-200302140-00005.

    PMID: 12556685BACKGROUND

  • Morrow K, Rosen R, Richter L, Emans A, Forbes A, Day J, Morar N, Maslankowski L, Profy AT, Kelly C, Abdool Karim SS, Mayer KH. The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial. J Womens Health (Larchmt). 2003 Sep;12(7):655-66. doi: 10.1089/154099903322404302.

    PMID: 14583106BACKGROUND

  • Tabet SR, Callahan MM, Mauck CK, Gai F, Coletti AS, Profy AT, Moench TR, Soto-Torres LE, Poindexter III AN, Frezieres RG, Walsh TL, Kelly CW, Richardson BA, Van Damme L, Celum CL. Safety and acceptability of penile application of 2 candidate topical microbicides: BufferGel and PRO 2000 Gel: 3 randomized trials in healthy low-risk men and HIV-positive men. J Acquir Immune Defic Syndr. 2003 Aug 1;33(4):476-83. doi: 10.1097/00126334-200308010-00008.

    PMID: 12869836BACKGROUND

MeSH Terms

Conditions

HIV InfectionsGonorrheaChlamydia InfectionsHerpes GenitalisSexual Behavior

Interventions

naphthalenesulfonic acid, polymer with formaldehyde

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialChlamydiaceae InfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital DiseasesBehavior

Study Officials

  • Sheena McCormack, MBBS, MSc, FRCP

    MRC Clinical Trials Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2005

First Posted

December 6, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2008

Study Completion

September 1, 2009

Last Updated

September 10, 2012

Record last verified: 2012-09

Locations

ZA(3)UG(1)TA(1)