HIV InfectionsPhase 3NCT00000926
A Study of Nonoxynol-9 (N-9) and HIV Infection
A Phase 3 study testing Nonoxynol-9 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV. Most of the people with HIV in the world today live in southern Africa. Because this population is not likely to use condoms, an HIV-prevention method that women can control is needed. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nonoxynol-9
- How many people
- 4,400 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Feb 2001
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers may be eligible if they:
- Are HIV-negative.
- Are sexually active and expect to have vaginal intercourse at least twice a week during the study.
- Are willing to keep a diary of their sexual behavior and N-9 use.
- Are willing to have regular clinic visits including pelvic exams.
- Are at least 18 years old.
- Are female.
Who cannot join
- Volunteers will not be eligible if they:
- Have had a child or an abortion in the past 42 days.
- Are allergic to latex or N-9.
- Have genital sores.
- Have syphilis, chlamydia, gonorrhea, or trichomoniasis.
- Are enrolled in another study for a product like N-9.
- Expect to use another vaginal product other than N-9 during the study.
- Are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Julia Welch
Research Triangle Park, North Carolina, 27709
About this study
Official title: Phase III Nonoxynol-9 and HIV Infection
The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV.
Most of the people with HIV in the world today live in southern Africa. Because this population is not likely to use condoms, an HIV-prevention method that women can control is needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases.
Read the detailed description
Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, dictate the need for prophylactic methods women can control.
This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.
- Conditions
- HIV Infections
- Being tested
- Nonoxynol-9
- Keywords
- Nonoxynol
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonoxynol-9Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Masking
- Double blind
- Enrolment
- 4,400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Taha E.Taha, Study chairNancy Padian, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000926
- Sponsor's protocol ID
- HIVNET 016 Pilot
- Other IDs
- 11712, HIVNET 016
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Kumwenda N, Hoffman I, Chirenje M, Kelly C, Coletti A, Ristow A, Martinson F, Brown J, Chilongozi D, Richardson B, Rosenberg Z, Padian N, Taha T. HIV incidence among women of reproductive age in Malawi and Zimbabwe. Sex Transm Dis. 2006 Nov;33(11):646-51. doi: 10.1097/01.olq.0000223283.27142.9f.
PubMed 16773032
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Nonoxynol-9 and HIV Infection
- ClinicalTrials.gov ID
- NCT00000926
- Acronym / sponsor ID
- HIVNET 016 Pilot
- Conditions
- HIV Infections
- Keywords
- Nonoxynol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,400 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Feb 2001 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if nonoxynol-9 (N-9) gel used in the vagina can prevent the spread of HIV.
Most of the people with HIV in the world today live in southern Africa. Because this population is not likely to use condoms, an HIV-prevention method that women can control is needed. N-9 used in the vagina may help prevent the spread of HIV and other sexually transmitted diseases.
Detailed description
Intravaginal application of N-9 may help protect women from HIV and other STD infection. Low rates of condom use in sub-Saharan African populations, which constitute the majority of HIV infections, dictate the need for prophylactic methods women can control.
This trial will be conducted in Zimbabwe and Malawi. The Phase III trial is preceded by a 2-week safety and acceptability pilot study to determine the extent of genital irritation caused by N-9 and the placebo. Following the pilot study and prior to screening for enrollment in the Phase III trial, potential volunteers will participate in a 2-month behavioral counseling program that will encourage the use of condoms. Only participants who decide they cannot or will not be consistent condom users are enrolled in the main study. Study participants are given N-9 gel or placebo to use each time they have vaginal sexual intercourse for 18 to 36 months. Participants have a follow-up evaluation once a month; a pelvic exam and blood tests are performed every third month.
Study design
- Primary purpose
- Prevention
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-negative.
- Are sexually active and expect to have vaginal intercourse at least twice a week during the study.
- Are willing to keep a diary of their sexual behavior and N-9 use.
- Are willing to have regular clinic visits including pelvic exams.
- Are at least 18 years old.
Key exclusion criteria (8 listed)
- Have had a child or an abortion in the past 42 days.
- Are allergic to latex or N-9.
- Have genital sores.
- Have syphilis, chlamydia, gonorrhea, or trichomoniasis.
- Are enrolled in another study for a product like N-9.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonoxynol-9 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Results publication: PubMed 16773032Kumwenda N, Hoffman I, Chirenje M, Kelly C, Coletti A, Ristow A, Martinson F, Brown J, Chilongozi D, Richardson B, Rosenberg Z, Padian N, Taha T. HIV incidence among women of reproductive age in Malawi and Zimbabwe. Sex Transm Dis. 2006 Nov;33(11):646-51. doi: 10.1097/01.olq.0000223283.27142.9f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taha E.Taha study chair
Nancy Padian study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nonoxynol-9 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 7 inclusion and 8 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 29 Oct 2021. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000926, 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 29 Oct 2021.