HIV InfectionsNCT01618058
Observational Study of HIV Infection in Participants of Seroconvert During Dapivirine Vaginal Ring Trials
An observational study of HIV Infections, run by International Partnership for Microbicides, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- No Investigational Product
- How many people
- 151 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 Oct 2012to 6 Aug 2019
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion. This study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.
Who may be able to join
- Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial
- Ability and willingness to provide informed consent
- Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing.
Who cannot join
- Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
South Africa4 sites
Madibeng Centre for Research (MCR)
Brits, 0250
Qhakaza Mbokodo
Ladysmith, KwaZulu-Natal
Prevention for HIV and AIDS Project (PHIVA)
Pinetown, KwaZulu-Natal
Maternal, Adolescent and Child Health (MatCH)
Plessislaer, 3216
About this study
Official title: A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials
The purpose of this trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.
- Conditions
- HIV Infections
- Being tested
- No Investigational Product
- Keywords
- HIV Infections, Anti-HIV Agents, HIV-1
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Investigational ProductDrug
This study is observational in nature and no investigational product will be used.
Groups: ARV-Treated Participants, ARV-Naive Participants
| Study group | Role | What they receive |
|---|---|---|
| ARV-Treated Participants | Those participants who received dapivirine during HIV seroconversion Receives: Drug: No Investigational Product | |
| ARV-Naive Participants | Those participants who received placebo during HIV seroconversion Receives: Drug: No Investigational Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo.
The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study start4 Oct 2012
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Linda-Gail Bekker, Study chair, Desmond Tutu HIV Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618058
- Sponsor's protocol ID
- IPM 007
- Status last verified
- Sep 2019
- First submitted
- 8 Jun 2012
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steytler J, van der Ryst E, Craig C, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; IPM 007 Study Team. Clinical Presentation, Treatment Response, and Virology Outcomes of Women Who Seroconverted in the Dapivirine Vaginal Ring Trials-The Ring Study and DREAM. Clin Infect Dis. 2023 Feb 8;76(3):389-397. doi: 10.1093/cid/ciac804.
PubMed 36189636
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Observational Cohort Study of HIV Infection in Participants Who Seroconvert After Enrolment in Dapivirine Vaginal Ring Trials
- ClinicalTrials.gov ID
- NCT01618058
- Acronym / sponsor ID
- IPM 007
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Anti-HIV Agents, HIV-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 13 Jun 2012 (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 trial is to determine if exposure to ARV-containing investigational products in IPM clinical trials will impact the natural history of HIV infection as measured by the virologic, immunologic and clinical outcomes of participants who become HIV-positive during the IPM 027 trial.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARV-Treated Participants | – | Drug: No Investigational ProductThose participants who received dapivirine during HIV seroconversion |
| ARV-Naive Participants | – | Drug: No Investigational ProductThose participants who received placebo during HIV seroconversion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Both microbicide and placebo recipients in IPM 027 who have become HIV infected (HIV-1 or HIV-2) while participating in IPM 027 will be offered enrolment in IPM 007 at the exit visit of IPM 027, i.e. approximately 6 weeks after identification of HIV seroconversion. This study includes all active IPM clinical research centres that enrol participants for IPM microbicide trials.
Key inclusion criteria (3 listed)
- Recent HIV seroconversion during participation in IPM 027, according to the HIV testing algorithm of that trial
- Ability and willingness to provide informed consent
- Willingness to give the research centre permission to share information with the primary health care provider (PHCP), and willingness to sign approved site-specific documentation to facilitate such sharing.
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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 |
|---|---|---|
| No Investigational ProductThis study is observational in nature and no investigational product will be used. Groups: ARV-Treated Participants, ARV-Naive Participants | Drug | ARV-Naive Participants, ARV-Treated Participants |
Primary outcome
To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo.
Time frame: 12 months
The primary outcome will be assessed by viral genotype assay at baseline and at exit from the protocol, to assess the occurrence and frequency of acquiring a drug resistant HIV virus during follow-up.
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 6 Sep 2019.
- Derived from this study: PubMed 36189636Steytler J, van der Ryst E, Craig C, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; IPM 007 Study Team. Clinical Presentation, Treatment Response, and Virology Outcomes of Women Who Seroconverted in the Dapivirine Vaginal Ring Trials-The Ring Study and DREAM. Clin Infect Dis. 2023 Feb 8;76(3):389-397. doi: 10.1093/cid/ciac804.
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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.
Linda-Gail Bekker study chair
Desmond Tutu HIV Centre
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by International Partnership for Microbicides, Inc. at 5 sites in 2 countries.
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 3 inclusion and 1 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa, Rwanda. 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.
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.
What does the primary outcome measure?
To identify HIV drug resistant mutations following recent seroconversion in plasma and vaginal secretions and change in resistant mutations over time in participants previously exposed to an ARV-based microbicide or a placebo. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01618058, 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 6 Sep 2019.