HIV InfectionsPhase 2NCT00592124
Adherence and Acceptability to and Blood Levels of Tenofovir Gel and Tablets in HIV Uninfected Women
A Phase 2 study testing Tenofovir disoproxil fumarate and Tenofovir gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 3 countries.
Trial summary
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. 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?
- Tenofovir disoproxil fumarate and Tenofovir gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jun 2008to Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- General good health
- HIV-uninfected
- Normal menstrual cycle. More information can be found in the protocol.
- Creatinine clearance greater than 70 ml/min
- Sexually active. More information can be found in the protocol.
- Normal Pap smear result within 12 months prior to study entry
- Agrees to not participate in other investigational studies
- Willing to use effective forms of contraception. More information can be found in the protocol.
Who cannot join
- Adverse reaction to either of the study products
- Adverse reaction to latex
- Currently sexually active with a partner with history of adverse reaction to latex
- More than three sexual partners in the month prior to screening
- Pathologic bone fracture not related to trauma
- Last pregnancy outcome within 90 days or less prior to enrollment
Show all 16Show fewer
- Gynecologic or genital procedure within 90 days of study entry
- Enrollment in other investigational study within 30 days of study entry
- Nontherapeutic injection drug use within 12 months of screening
- Any social or medical condition that, in the opinion of the investigator, would interfere with the study
- Abnormal laboratory values
- Grade 2 or higher genital lesions, erythema, and/or edema or has any other abnormal physical or pelvic exam finding that, in the opinion of the investigator, would interfere with the study
- Kidney, reproductive, or urinary tract infection requiring treatment. More information on this criterion can be found in the protocol.
- Pregnant, breastfeeding, or intend to become pregnant
- Unwilling to comply with study participation requirements, including attendance at all scheduled study visits
- Per participant report, use of the following at enrollment, and/or anticipated use during the period of study participation - use of a diaphragm, vaginal ring, and/or spermicide for contraception, acyclovir or valacyclovir, post-exposure prophylaxis for HIV exposure, TDF/emtricitabine, non-study vaginal products
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Alabama Microbicide CRS
Birmingham, Alabama, 35294
Case CRS
Cleveland, Ohio, 44106
Pitt CRS
Pittsburgh, Pennsylvania, 15213-2582
Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)
The Bronx, New York
South Africa2 sites
Botha's Hill CRS
Durban, KwaZulu-Natal
Umkomaas CRS
Durban, KwaZulu-Natal
Uganda1 site
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala
About this study
Official title: Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
A new approach to HIV prevention currently being studied includes the use of microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.
Read the detailed description
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to and blood levels of the two interventions in three separate regimens given to HIV-uninfected women.
The expected duration of participation for each participant is 21 weeks. Study participants will be randomly assigned into one of six study groups, each with a different regimen sequence. Each sequence will consist of three study periods and three wash-out periods. Each study period lasts 6 weeks, followed by a 1 week wash-out period. The regimen assigned for a given study period will include either oral TDF, tenofovir vaginal gel, or both. All participants will be prescribed all three regimens in the order designated by their randomized assignment.
Study visits will occur at Weeks 1, 3, 6, 7, 10, 13, 14, 17, 20, and 21. Medical history, a physical exam, behavioral assessment, and urine, blood, pelvic sample collection, and counseling will occur at all visits. At some study sites rectal swabs may be performed. Counseling will include information regarding contraception, protocol adherence, HIV, HIV/Sexually Transmitted Infection risk reduction, and male condom use. Pharmacokinetic (PK) studies, to be determined by the study site, will occur during all three study periods. These studies may involve additional procedures.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate, Tenofovir gel
- Keywords
- Microbicide, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarateDrug
Also called TDF
300 mg tablet daily
Tenofovir gelDrug
Also called TFV, 9-[2-(Phosphonomethoxy)propyl]adenine
1 gm/100 ml of 1% gel vaginally daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
| 2 | Experimental | Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
| 3 | Experimental | Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
| 4 | Experimental | Oral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
| 5 | Experimental | Oral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
| 6 | Experimental | Vaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20 Receives: Drug: Tenofovir disoproxil fumarate; Drug: Tenofovir gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Adherence to Each Regimen
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
Measured: Measured through Week 21
Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future
Measured: Measured through Week 21
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.
Measured: Measured through Week 21
Secondary outcomes (15)
Frequency of Product Use
This number represents how often participant used study product during the preceding 3 weeks and is measured twice during each 6 week product period.
Measured: Measured through Week 21
Number of Days Product Missed
This represents the longest number of days in a row during the past 3 weeks that a participant missed using the study product.
Measured: Measured through Week 21
Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses
Measured: Measured through Week 21
Frequency of Sexual Activity
This represents the rate during the past 3 weeks at which participants engaged in vaginal sex.
Measured: Measured through Week 21
Frequency of Male Condom Use
Measured: Measured through Week 21
Tablet Usage Before Sex
These summaries represent counts and percentages of participants using tablet before last instance of vaginal sex.
Measured: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used before the encounter).
Measured: Measured through Week 21
Tablet Usage After Sex
These summaries represent counts and percentages of participants using tablet after last instance of vaginal sex.
Measured: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given tablet was used after the encounter).
Measured: Measured through Week 21
Gel Usage Before Sex
These summaries represent counts and percentages of participants using gel before last instance of vaginal sex.
Measured: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used before the encounter).
Measured: Measured through Week 21
Gel Usage After Sex
These summaries represent counts and percentages of participants using gel after last instance of vaginal sex.
Measured: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
Median and inter-quartile range of the time between product usage and instance of vaginal intercourse (given gel was used after the encounter).
Measured: Measured through Week 21
Reported Sharing of Product
Number and percentage of participants who had a product sharing event during the 6-week product use period, where a sharing event includes 1) being asked for the study product, or 2) selling, trading, or giving away study product, or 3) having someone take the study product from the participant.
Measured: Measured through Week 21
Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
Measured: Measured through Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Microbicide Trials Network
- Responsible party
- Sponsor
- Investigators
- Craig W. Hendrix, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592124
- Sponsor's protocol ID
- MTN-001
- Other IDs
- 10617, 1U01AI068633-01
- Status last verified
- Jan 2017
- First submitted
- 31 Dec 2007
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
PubMed 17805450Mayer 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 16470118Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30.
PubMed 23383037Minnis AM, van der Straten A, Salee P, Hendrix CW. Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions. AIDS Behav. 2016 Jul;20(7):1541-8. doi: 10.1007/s10461-015-1081-3.
PubMed 25969178Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, Patterson K, Gomez K, Hendrix CW. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013 Feb;17(2):737-47. doi: 10.1007/s10461-012-0333-8.
PubMed 23065145
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Adherence and Pharmacokinetics Study of Oral and Vaginal Preparations of Tenofovir
- ClinicalTrials.gov ID
- NCT00592124
- Acronym / sponsor ID
- MTN-001
- Conditions
- HIV Infections
- Keywords
- Microbicide, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Microbicide Trials Network
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 27 Feb 2017
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 microbicides, substances that kill microbes. Tenofovir disoproxil fumarate (TDF) is an oral, FDA-approved, anti-HIV drug, and tenofovir gel is an experimental microbicide. The purpose of this study is to determine the adherence and acceptability to and blood levels of three daily regimens of tenofovir in both oral and gel form.
Detailed description
It is necessary to monitor both the adherence and blood levels of microbicides in order to gauge its efficacy in a study population. Utilizing an experimental microbicide (tenofovir gel) and an anti-HIV drug (TDF), this study will measure the adherence and acceptability to and blood levels of the two interventions in three separate regimens given to HIV-uninfected women.
The expected duration of participation for each participant is 21 weeks. Study participants will be randomly assigned into one of six study groups, each with a different regimen sequence. Each sequence will consist of three study periods and three wash-out periods. Each study period lasts 6 weeks, followed by a 1 week wash-out period. The regimen assigned for a given study period will include either oral TDF, tenofovir vaginal gel, or both. All participants will be prescribed all three regimens in the order designated by their randomized assignment.
Study visits will occur at Weeks 1, 3, 6, 7, 10, 13, 14, 17, 20, and 21. Medical history, a physical exam, behavioral assessment, and urine, blood, pelvic sample collection, and counseling will occur at all visits. At some study sites rectal swabs may be performed. Counseling will include information regarding contraception, protocol adherence, HIV, HIV/Sexually Transmitted Infection risk reduction, and male condom use. Pharmacokinetic (PK) studies, to be determined by the study site, will occur during all three study periods. These studies may involve additional procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelOral tenofovir disoproxil fumarate (TDF) for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20 |
| 2 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelVaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and oral TDF and vaginal tenofovir gel application for Weeks 15 through 20 |
| 3 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelOral TDF and vaginal tenofovir gel application for Weeks 1 through 6, oral TDF for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20 |
| 4 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelOral TDF and vaginal tenofovir gel application for Weeks 1 through 6, vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20 |
| 5 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelOral TDF for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and vaginal tenofovir gel application for Weeks 15 through 20 |
| 6 | Experimental | Drug: Tenofovir disoproxil fumarate, Drug: Tenofovir gelVaginal tenofovir gel application for Weeks 1 through 6, oral TDF and vaginal tenofovir gel application for Weeks 8 through 13, and oral TDF for Weeks 15 through 20 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- General good health
- HIV-uninfected
- Normal menstrual cycle. More information can be found in the protocol.
- Creatinine clearance greater than 70 ml/min
- Sexually active. More information can be found in the protocol.
Key exclusion criteria (16 listed)
- Adverse reaction to either of the study products
- Adverse reaction to latex
- Currently sexually active with a partner with history of adverse reaction to latex
- More than three sexual partners in the month prior to screening
- Pathologic bone fracture not related to trauma
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 |
|---|---|---|
| Tenofovir disoproxil fumarateAlso: TDF300 mg tablet daily | Drug | 1, 2, 3, 4, 5, 6 |
| Tenofovir gelAlso: TFV, 9-[2-(Phosphonomethoxy)propyl]adenine1 gm/100 ml of 1% gel vaginally daily | Drug | 1, 2, 3, 4, 5, 6 |
Primary outcome
Self-reported Adherence to Each Regimen
Time frame: Measured through Week 21
Participant self-reported product use. For each woman, adherence to each regimen was computed by dividing the number of daily doses she reported having taken by the number of doses expect if she were fully adherent.
Proportion of Participants Who Indicate They Would be "Unlikely" Use Study Product in the Future
Time frame: Measured through Week 21
Systemic and Local PK Among Three Regimens of Tenofovir (Oral, Vaignal, and Dual Use)
Time frame: Measured through Week 21
PK measures, including maximum concentrations (Cmax) in serum, tissue, and cervicovaginal lavage.
15 secondary outcomes
Frequency of Product Use
Time frame: Measured through Week 21
Number of Days Product Missed
Time frame: Measured through Week 21
Proportion of Women Who Report Taking at Least 90% of Expected Daily Doses
Time frame: Measured through Week 21
Frequency of Sexual Activity
Time frame: Measured through Week 21
Frequency of Male Condom Use
Time frame: Measured through Week 21
Tablet Usage Before Sex
Time frame: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place After Using Tablet.
Time frame: Measured through Week 21
Tablet Usage After Sex
Time frame: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place Before Using Tablet.
Time frame: Measured through Week 21
Gel Usage Before Sex
Time frame: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place After Using Gel.
Time frame: Measured through Week 21
Gel Usage After Sex
Time frame: Measured through Week 21
Length of Time Vaginal Sexual Intercourse Took Place Before Using Gel.
Time frame: Measured through Week 21
Reported Sharing of Product
Time frame: Measured through Week 21
Grade 3 or Higher Toxicity for Systemic and Local Effects as Defined by the Protocol
Time frame: Measured through Week 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17805450Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
- 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.
- Results publication: PubMed 23383037Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30.
- Derived from this study: PubMed 25969178Minnis AM, van der Straten A, Salee P, Hendrix CW. Pre-exposure Prophylaxis Adherence Measured by Plasma Drug Level in MTN-001: Comparison Between Vaginal Gel and Oral Tablets in Two Geographic Regions. AIDS Behav. 2016 Jul;20(7):1541-8. doi: 10.1007/s10461-015-1081-3.
- Derived from this study: PubMed 23065145Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, Nakabiito C, Hoesley C, Justman J, Soto-Torres L, Patterson K, Gomez K, Hendrix CW. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013 Feb;17(2):737-47. doi: 10.1007/s10461-012-0333-8.
- 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.
Craig W. Hendrix, MD study chair
Johns Hopkins University
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenofovir disoproxil fumarate and Tenofovir gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 3 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 8 inclusion and 16 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 19 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 7 sites in United States, South Africa, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported Adherence to Each Regimen (time frame: Measured through Week 21). The study lists 3 primary outcomes in all. 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 NCT00592124, which also lists 5 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 19 Oct 2021.