HIV InfectionsNCT00729573
Bone Mineral Density Substudy - An Ancillary Study to MTN-003
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
Trial summary
The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Emtricitabine/tenofovir disoproxil fumarate and Tenofovir disoproxil fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2009to May 2013
- 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
- Healthy volunteers accepted
- Adult
Study population: Sexually active, HIV-uninfected women who are currently enrolled in MTN-003
Who may be able to join
- Enrolled in MTN-003
- Randomized to oral study product in MTN-003 within 14 days prior to study entry
Who cannot join
- Medical condition known to affect bone or taking any medication known to affect bone. More information on this criterion can be found in the protocol.
- Permanently discontinued from oral study product in MTN-003 prior to study entry
- Any condition that, in the opinion of the investigator, would interfere with the study
- Pregnant
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Zimbabwe3 sites
Seke South CRS
Chitungwiza
Zengeza CRS
Chitungwiza
Spilhaus CRS
Harare
About this study
Official title: Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).
Read the detailed description
The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo.
This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 48 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy.
Study visits will occur every 6 months after enrollment. A nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.
- Conditions
- HIV Infections
- Being tested
- Emtricitabine/tenofovir disoproxil fumarate, Emtricitabine/tenofovir disoproxil fumarate placebo, Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate placebo
- Keywords
- Microbicide, HIV Seronegativity, Bone Mineral Density
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine/tenofovir disoproxil fumarateDrug
Also called FTC/TDF, Truvada
200 mg/300 mg tabletas a part of MTN-003
Emtricitabine/tenofovir disoproxil fumarate placeboDrug
Also called FTC/TDF placebo, Truvada placebo
placebo tablet as a part of MTN-003
Tenofovir disoproxil fumarateDrug
Also called TDF
300 mg tablet as a part of MTN-003
Tenofovir disoproxil fumarate placeboDrug
Also called TDF placebo
placebo tablet as a part of MTN-003
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups. Receives: Drug: Emtricitabine/tenofovir disoproxil fumarate; Drug: Emtricitabine/tenofovir disoproxil fumarate placebo; Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir disoproxil fumarate placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone mineral density
Measured: Throughout study
Secondary outcomes (1)
Changes in nutrition
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Microbicide Trials Network
- Responsible party
- Sponsor
- Investigators
- Sharon A. Riddler, MD, MPH, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729573
- Sponsor's protocol ID
- MTN-003B
- Other IDs
- 10709
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2008
- Last updated
- 8 Feb 2023
- Results posted
- No
Publications
Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.
PubMed 16470118Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, Gai F, Maslankowski L, El-Sadr WM, Mayer KH. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325.
PubMed 18328009
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women
- ClinicalTrials.gov ID
- NCT00729573
- Acronym / sponsor ID
- MTN-003B
- Conditions
- HIV Infections
- Keywords
- Microbicide, HIV Seronegativity, Bone Mineral Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Microbicide Trials Network
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Aug 2008 (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 MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).
Detailed description
The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo.
This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 48 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy.
Study visits will occur every 6 months after enrollment. A nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Emtricitabine/tenofovir disoproxil fumarate, Drug: Emtricitabine/tenofovir disoproxil fumarate placebo, Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir disoproxil fumarate placeboParticipants in MTN-003. Participants will remain a part of their assigned MTN-003 study groups. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sexually active, HIV-uninfected women who are currently enrolled in MTN-003
Key inclusion criteria (2 listed)
- Enrolled in MTN-003
- Randomized to oral study product in MTN-003 within 14 days prior to study entry
Key exclusion criteria (4 listed)
- Medical condition known to affect bone or taking any medication known to affect bone. More information on this criterion can be found in the protocol.
- Permanently discontinued from oral study product in MTN-003 prior to study entry
- Any condition that, in the opinion of the investigator, would interfere with the study
- Pregnant
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 |
|---|---|---|
| Emtricitabine/tenofovir disoproxil fumarateAlso: FTC/TDF, Truvada200 mg/300 mg tabletas a part of MTN-003 | Drug | 1 |
| Emtricitabine/tenofovir disoproxil fumarate placeboAlso: FTC/TDF placebo, Truvada placeboplacebo tablet as a part of MTN-003 | Drug | 1 |
| Tenofovir disoproxil fumarateAlso: TDF300 mg tablet as a part of MTN-003 | Drug | 1 |
| Tenofovir disoproxil fumarate placeboAlso: TDF placeboplacebo tablet as a part of MTN-003 | Drug | 1 |
Primary outcome
Changes in bone mineral density
Time frame: Throughout study
1 secondary outcome
Changes in nutrition
Time frame: Throughout study
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 8 Feb 2023.
- Background: PubMed 16470118Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.
- Background: PubMed 18328009Rosen RK, Morrow KM, Carballo-Dieguez A, Mantell JE, Hoffman S, Gai F, Maslankowski L, El-Sadr WM, Mayer KH. Acceptability of tenofovir gel as a vaginal microbicide among women in a phase I trial: a mixed-methods study. J Womens Health (Larchmt). 2008 Apr;17(3):383-92. doi: 10.1089/jwh.2006.0325.
- 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, MPH study chair
University of Pittsburgh
4 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 National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 2 inclusion and 4 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Zimbabwe, Uganda. 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?
Changes in bone mineral density (time frame: Throughout study). 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 NCT00729573, which also lists 2 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 8 Feb 2023.