HIV InfectionsPhase 4NCT00344760
A Study to Evaluate of the Efficacy of Enfuvirtide During the Induction Phase of Therapy
A Phase 4 study testing Enfuvirtide and Efavirenz, lamivudine, and tenofovir in people with HIV Infections, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Enfuvirtide and Efavirenz, lamivudine, and tenofovir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 70 years of age.
- Sex: Male or Female.
- Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.
- Naïve to HAART.
- Viral load >100,000c/ml.
- CD4<200c/ml.
- Volunteers must be willing and able to provide written informed consent to participate in the study.
- Available for at least 48 weeks of follow-up.
Who cannot join
- Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.
- Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.
- Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)
- Patients with malabsorption or severe chronic diarrhea for more than 30 days.
- Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).
- Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
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- Any other medical condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results.
- Pregnancy or breastfeeding
- In a female capable of child bearing, unwillingness to use effective barrier contraception or abstinence
- Patient who is currently receiving an experimental medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201
About this study
Official title: Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.
Read the detailed description
This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.
All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).
- Conditions
- HIV Infections
- Being tested
- Enfuvirtide, Efavirenz, lamivudine, and tenofovir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnfuvirtideDrug
Also called Fuzeon (T-20)
subcutaneously twice a day
Efavirenz, lamivudine, and tenofovirDrug
Also called Atripla, Epivir and Viread
Efavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | Efavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily Receives: Drug: Efavirenz, lamivudine, and tenofovir |
| Standard Treatment Plus Enfuvirtide | Experimental | Efavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first). Receives: Drug: Enfuvirtide; Drug: Efavirenz, lamivudine, and tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to viral suppression below 50c/ml.
The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress
Measured: Individual
Secondary outcomes (11)
Log viral copy/ml decrease over time during phase 1 and phase 2.
Measured: Over the 48 week study period
Development of clinical mutations.
Measured: Over the 48 week study period
Development of sub-clinical mutations (minority variants)
Measured: Over the 48 week study period
Viral suppression (below 50c/ml) at 24 and 48 weeks.
Measured: At 24 and 48 weeks
Time to loss of viral response. Loss of viral response defined as:
Measured: Over the 48 week study period
Less then 2.0 log decrease in viral load at week 8.
Measured: Week 8
Inability to achieve Viral load <50c/ml by week 12.
Measured: Week 12
Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral
Measured: Over the 48 week study period
suppression <50c/ml has occurred
Measured: Over the 48 week study period
Rate and quantity of HIV-1 proviral DNA decay.
Measured: Over the 48 week study period
Safety and tolerability.
Measured: Over the 48 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald B Reisler, MD, MPH, Principal investigator, University of Maryland, School of Medicine, Department of Infectious Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344760
- Sponsor's protocol ID
- H-26280
- Status last verified
- May 2021
- First submitted
- 23 Jun 2006
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Decay Kinetics During Induction Therapy With or Without the Use of Enfuvirtide in HAART-naÃ-ve Patients With Advanced HIV
- ClinicalTrials.gov ID
- NCT00344760
- Acronym / sponsor ID
- H-26280
- Conditions
- HIV Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Jun 2006 (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.
We hypothesize that using a potent antiretroviral such as Enfuvirtide during the induction phase of HAART therapy will lead to faster clearance of virus and infected cells, and lower number of minority variant HIV-1 strains.
Detailed description
This is an 48 week Phase 4, open label, randomized, prospective, pilot proof of concept study to evaluate the use of Enfuvirtide in an induction/maintenance treatment model. Patients meeting inclusion criteria will be stratified into two groups according to HIV-1 RNA viral loads (less than 300,000 copies/ml and greater than 300,000 copies/ml). Thereafter, patients will be block randomized (the size of each block will be two patients) into one of two treatment arms.
All patients will receive Efavirenz 600mg once a day, Lamivudine 300 mg once a day, and Tenofovir 300mg once a day. After randomization, one half of the patients will receive no additional treatment, while the other half will receive Enfuvirtide 90mg sq BID until the viral load is <50 x 2 consecutive visits or 12 weeks (whichever comes first).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: Efavirenz, lamivudine, and tenofovirEfavirenz 600mg once daily, Lamivudine 300mg once daily and Tenofovir 300mg once daily |
| Standard Treatment Plus Enfuvirtide | Experimental | Drug: Enfuvirtide, Drug: Efavirenz, lamivudine, and tenofovirEfavirenz 600mg once daily, Lamivudine 300mg once daily, Tenofovir 300mg once daily and enfuvirtide 90mg subcutaneously twice a day until the viral load is less than 50copies for 2 consecutive visits or 12 weeks (whichever comes first). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 to 70 years of age.
- Sex: Male or Female.
- Documented HIV-1 seropositive by Western Blot, Elisa, or HIV-1 viral load.
- Naïve to HAART.
- Viral load >100,000c/ml.
Key exclusion criteria (10 listed)
- Volunteers with an acute and clinically significant medical event as determined by the investigator to result in a life expectancy less then 12 months despite ART.
- Volunteers with current psychiatric illness, alcohol abuse or illicit drug use that in the opinion of the Principal Investigator may interfere with patient's ability to comply with protocol requirements.
- Renal insufficiency (Estimated Creatinine clearance of <60ml/min.)
- Patients with malabsorption or severe chronic diarrhea for more than 30 days.
- Inability to consume adequate oral intake (defined as inability to eat at least 1 meal per day).
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 |
|---|---|---|
| EnfuvirtideAlso: Fuzeon (T-20)subcutaneously twice a day | Drug | Standard Treatment Plus Enfuvirtide |
| Efavirenz, lamivudine, and tenofovirAlso: Atripla, Epivir and VireadEfavirenz -600mg once daily, lamivudine- 300mg once daily, and tenofovir 300mg once daily | Drug | Standard Treatment, Standard Treatment Plus Enfuvirtide |
Primary outcome
Time to viral suppression below 50c/ml.
Time frame: Individual
The study is 48 weeks long and the time to viraL suppression will vary depending on the subject. Or there is the possibility that they do not supress
11 secondary outcomes
Log viral copy/ml decrease over time during phase 1 and phase 2.
Time frame: Over the 48 week study period
Development of clinical mutations.
Time frame: Over the 48 week study period
Development of sub-clinical mutations (minority variants)
Time frame: Over the 48 week study period
Viral suppression (below 50c/ml) at 24 and 48 weeks.
Time frame: At 24 and 48 weeks
Time to loss of viral response. Loss of viral response defined as:
Time frame: Over the 48 week study period
Less then 2.0 log decrease in viral load at week 8.
Time frame: Week 8
Inability to achieve Viral load <50c/ml by week 12.
Time frame: Week 12
Viral load >50c/ml on 2 consecutive measurements taken 2 weeks apart after viral
Time frame: Over the 48 week study period
suppression <50c/ml has occurred
Time frame: Over the 48 week study period
Rate and quantity of HIV-1 proviral DNA decay.
Time frame: Over the 48 week study period
Safety and tolerability.
Time frame: Over the 48 week study period
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 11 May 2021.
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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.
Ronald B Reisler, MD, MPH principal investigator
University of Maryland, School of Medicine, Department of Infectious Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enfuvirtide and Efavirenz, lamivudine, and tenofovir in people with HIV Infections, run by University of Maryland, Baltimore 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 8 inclusion and 10 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 11 May 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Time to viral suppression below 50c/ml. (time frame: Individual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2021.