HIV InfectionsNCT00514098
Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials
An observational study of HIV Infections, run by Microbicide Trials Network at 18 sites in 5 countries.
Trial summary
A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- HIV Infections
- How many people
- 479 participants
- Where
- 18 sitesin 5 countries
- Study dates
- 25 Aug 2008to 30 Jun 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who are diagnosed with HIV-1 during participation in previous microbicide trials
Who may be able to join
- Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study
Trial locations and contacts
18 sites in 5 countries.
18 sites in 5 countries
South Africa11 sites
Botha's Hill CRS
Durban, KwaZulu-Natal, 3660
CAPRISA eThewkini
Durban, KwaZulu-Natal, 4001
Overport CRS
Durban, KwaZulu-Natal, 4091
Isipingo CRS
Durban, KwaZulu-Natal, 4133
Verulam CRS
Durban, KwaZulu-Natal, 4390
South African Medical Research Council, Tongaat
Durban, KwaZulu-Natal
Umkomaas CRS
Durban, KwaZulu-Natal
R. K. Khan CRS
Durban
Wits Reproductive Health Institute (WRHI)
Johannesburg, Gauteng, 2001
CAPRISA- The Aurum Institute
Johannesburg, Guateng, 2571
Perinatal HIV Research Unit (HPRU)
Johannesburg, Soweto, 1804
Zimbabwe3 sites
Seke South CRS
Chitungwiza
UZ-UCSF HIV Prevention Trials Unit
Harare, Chitungwiza
Spilhaus CRS
Harare
Malawi2 sites
College of Med. JHU CRS
Blantyre
University of North Carolina Lilongwe
Lilongwe
Uganda1 site
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala
About this study
Official title: An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials
A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.
Read the detailed description
It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.
The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.
A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.
- Conditions
- HIV Infections
- Keywords
- Microbicide, Seroconversion, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections, HIV Seropositivity
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV disease progression comparison
To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.
Measured: 12 months
Secondary outcomes (4)
HIV disease progression comparison
To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.
Measured: Total duration of follow up
Virologic and immunologic response comparison
To compare virologic and immunologic responses following initiation of antiretroviral therapy among participants assigned to an active agent versus placebo/control participants.
Measured: Total duration of follow up
HIV-1 drug resistance profile comparison
To compare the HIV-1 drug resistance profile, among antiretroviral therapy recipients at the time of virologic failure in participants assigned to an active agent versus placebo/control participants.
Measured: Total duration of follow up
Sexual behavior and partnership status changes
To describe post seroconversion changes in sexual behaviors and partnership status of participants.
Measured: Total duration of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study start25 Aug 2008
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Microbicide Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sharon A. Riddler, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514098
- Sponsor's protocol ID
- MTN-015
- Other IDs
- 5UM1AI068633, 10529
- Status last verified
- Jun 2021
- First submitted
- 8 Aug 2007
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
PubMed 30346511Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One. 2017 Jun 28;12(6):e0178594. doi: 10.1371/journal.pone.0178594. eCollection 2017.
PubMed 28658251Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials. 2016 Sep;17(5):204-11. doi: 10.1080/15284336.2016.1212561. Epub 2016 Jul 28.
PubMed 27465646
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials
- ClinicalTrials.gov ID
- NCT00514098
- Acronym / sponsor ID
- MTN-015
- Conditions
- HIV Infections
- Keywords
- Microbicide, Seroconversion, Treatment Experienced, Treatment Naive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Microbicide Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 25 Aug 2008 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Aug 2007 (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.
A new approach to HIV prevention currently being studied includes the use of topical microbicides and orally administered anti-HIV drugs. The purpose of this study is to better understand the impact of microbicides in women who are diagnosed with HIV-1 during participation in previous microbicide trials.
Detailed description
It is necessary to monitor HIV over long periods of time in order to better understand the impact of microbicides and anti-HIV drugs on the progression of HIV infection in those who become infected or are unknowingly already infected while receiving these drugs. The purpose of this study is to determine the effects of microbicides or oral anti-HIV drugs over time in HIV infected women who were previously enrolled in other microbicide trials.
The study will remain open to accrual for the duration of MTN funding, and will use two follow-up visit schedules, one based on the date of diagnosis in the parent study, and one based on the initiation of antiretroviral treatment (ART). Participants who have not initiated ART at the time of enrollment in this study will follow the schedule based on the date of diagnosis. Participants who have already begun ART at the time of enrollment will follow the schedule based on the date of ART initiation. Individuals enrolled with a starting date based on the date of ART initiation will have their first follow-up visit at Week 2 before resuming the rest of the schedule. On both schedules, follow-up visits occur at Months 1, 3, and 6 and every 6 months thereafter. Interim visits may be performed at any time during follow-up, and participants will be asked to attend a final study visit prior to their termination from the study. Participants may enroll any time after their HIV diagnosis and can leave the study at any time.
A physical exam; medical and medication history assessment; blood and urine collection; and pelvic, cervicovaginal lavage, and vaginal swab sampling will occur at all visits. A behavioral assessment will occur at select visits, and adherence and social harms assessments will occur at most visits. Sexually transmitted infection risk reduction/contraception and HIV-1 secondary counseling will occur at most visits. In addition, condoms will be provided at all visits to reduce further HIV transmission. ART will not be provided by this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who are diagnosed with HIV-1 during participation in previous microbicide trials
Key inclusion criteria (2 listed)
- Diagnosis of HIV-1 infection during participation in any Microbicide Trials Network (MTN) clinical trial (including HPTN 035 and HPTN 059), according to the HIV testing algorithm of the parent MTN trial
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (1 listed)
- Any condition that, in the opinion of the investigator, makes participation in the study unsafe or interferes with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV disease progression comparison
Time frame: 12 months
To compare HIV disease progression 12 months post seroconversion among participants assigned to an active agent compared to placebo/control participants.
4 secondary outcomes
HIV disease progression comparison
Time frame: Total duration of follow up
Virologic and immunologic response comparison
Time frame: Total duration of follow up
HIV-1 drug resistance profile comparison
Time frame: Total duration of follow up
Sexual behavior and partnership status changes
Time frame: Total duration of 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 21 Jun 2021.
- Results publication: PubMed 30346511Riddler SA, Balkus JE, Parikh UM, Mellors JW, Akello C, Dadabhai S, Mhlanga F, Ramjee G, Mayo AJ, Livant E, Heaps AL, O'Rourke C, Baeten JM; MTN-015 and MTN-020/ASPIRE Study Teams. Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring. Clin Infect Dis. 2019 Jul 18;69(3):523-529. doi: 10.1093/cid/ciy909.
- Results publication: PubMed 28658251Riddler SA, Husnik M, Ramjee G, Premrajh A, Tutshana BO, Pather A, Siva S, Jeenarain N, Nair G, Selepe P, Kabwigu S, Palanee-Phillips T, Panchia R, Mhlanga F, Levy L, Livant E, Patterson K, Elharrar V, Balkus J. HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One. 2017 Jun 28;12(6):e0178594. doi: 10.1371/journal.pone.0178594. eCollection 2017.
- Results publication: PubMed 27465646Riddler SA, Husnik M, Gorbach PM, Levy L, Parikh U, Livant E, Pather A, Makanani B, Muhlanga F, Kasaro M, Martinson F, Elharrar V, Balkus JE; MTN-015 Protocol Team for the Microbicide Trials Network. Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015. HIV Clin Trials. 2016 Sep;17(5):204-11. doi: 10.1080/15284336.2016.1212561. Epub 2016 Jul 28.
- Click here for the Microbicide Trials Network Web siteLink provided by the sponsor.
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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.
Sharon A. Riddler, MD study chair
University of Pittsburgh
18 sites in 5 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 Microbicide Trials Network at 18 sites in 5 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 2 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Africa, Zimbabwe, Malawi, Uganda, Zambia. 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?
HIV disease progression comparison (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 NCT00514098, which also lists 3 linked publications.
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 21 Jun 2021.