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Sponsors and Collaborators: |
Indevus Pharmaceuticals Medical Research Council Department for International Development, United Kingdom |
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Information provided by: | Indevus Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00262106 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Gonorrhea Chlamydial Infections Genital Herpes |
Drug: PRO 200/5 |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of 0.5% and 2% PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection |
Estimated Enrollment: | 9673 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | August 2009 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: PRO 200/5
Gel
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PRO 2000/5 Gel 0.5%: Active Comparator |
Drug: PRO 200/5
Gel
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The HIV pandemic continues with an estimated 13,000 new infections each day, the vast majority of which are acquired through heterosexual intercourse. Although consistent and correct use of condoms by men remains the most effective form of protection from heterosexually acquired HIV, women are not always able to negotiate condom use. An effective prophylactic vaccine remains a key objective, but development is slow because of virus variability and difficulty in determining the immunological correlates of protection. Vaginal microbicides are being developed in response to the urgent need for an HIV prevention method that women can control. Licensed spermicides containing nonoxynol-9 (N-9), which has potent anti-HIV activity in vitro, were the first products to be investigated as potential microbicides. However, the association of N-9 and other products belonging to this class (surfactants) with genital epithelial disruption, histologically determined genital inflammation, and reduction in populations of vaginal lactobacilli led to concerns that their use could enhance the risk of HIV transmission. Early Phase 3 studies of N-9 products yielded conflicting results, but more recently, a multicenter randomized placebo-controlled trial of a low dose N-9 formulation demonstrated an increased incidence of HIV infection in the N-9 group compared to placebo. These findings have intensified efforts to develop agents with a more favorable toxicity profile. At least four of these have entered trials to assess effectiveness in preventing vaginally acquired HIV infection: Buffer Gel, Carraguard, cellulose sulfate and PRO 2000/5 Gel. Protocol MDP 301 describes a randomized placebo-controlled trial design to explore the safety and efficacy of two concentrations of PRO 2000/5 Gel.
The study is ongoing but no longer recruiting patients. Between October 2005 and August 2008 9395 eligible, sexually active, HIV-uninfected women were enrolled at six or more sites in Africa. Up until February 2008, participants were randomly assigned to 0.5% or 2% PRO 2000/5 Gel treatment arms or a placebo gel arm. Following a recommendation by the Independent Data Monitoring Committee that the 2% PRO2000/5 Gel treatment arm should not continue as there was no more than a small chance of demonstrating benefit, participants enrolled after February 13, 2008 were randomly assigned to the 0.5% PRO 200/5 gel treatment arm or placebo arm. Participants were instructed to apply a single dose of study gel 1 hour or less before every act of vaginal intercourse using a single-use pre-filled applicator. Participants also receive risk-reduction counseling and condoms, and STD testing. Most study participants will complete 12 months of follow-up. A cohort of sero-discordant couples enrolled in Uganda will be followed for up to 24 months. The expected total duration of the trial is 46 months.
The primary efficacy outcome measure is acquisition of HIV infection at the 9 month time point. Secondary outcomes include measures of HIV infection at the 6 and 12 month time points, infection by HSV-2, Neisseria gonorrhoeae, Chlamydia trachomatis, and adverse events.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa | |
HIV Prevention Research Unit, Medical Research Council | |
Westville, South Africa, 3630 | |
Reproductive Health and HIV Research Unit, Chris Hani Baragwanath Hospital | |
Bertsham, South Africa, 2013 | |
Africa Centre for Health and Population Studies | |
Mtubatuba, South Africa, 3935 | |
Tanzania | |
AMREF Lake Zone Programme | |
Mwanza, Tanzania | |
Uganda | |
MRC Programme on AIDS in Uganda, Uganda Virus Research Institute | |
Entebbe, Uganda | |
Zambia | |
MDP Zambia, Nakambala Sugar Estate | |
Mazabuka, Zambia |
Principal Investigator: | Sheena McCormack, MBBS, MSc, FRCP | MRC Clinical Trials Unit |
Study ID Numbers: | MDP301, ISRCTN64716212 |
Study First Received: | December 5, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00262106 |
Health Authority: | United States: Food and Drug Administration |
Administration, intravaginal Anti-infective agents Double blind method Drug evaluation Female Gels HIV infections/prevention and control |
Microbicide Naphthalenesulfonates/administration and dosage Polymers/administration and dosage Sexual behavior Vaginal creams, foams and jellies HIV Seronegativity Genital Herpes Infections |
Herpes Simplex Bacterial Infections Sexually Transmitted Diseases, Viral Herpes Genitalis Acquired Immunodeficiency Syndrome Genital Diseases, Male Immunologic Deficiency Syndromes Herpesviridae Infections Gram-Negative Bacterial Infections |
Genital Diseases, Female Virus Diseases HIV Infections Chlamydia Infections Sexually Transmitted Diseases DNA Virus Infections Gonorrhea Retroviridae Infections Neisseriaceae Infections |
Sexually Transmitted Diseases, Bacterial Communicable Diseases RNA Virus Infections Chlamydiaceae Infections |
Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |