HIV InfectionPhase 2NCT00013884
HIV Maintenance Therapy With T-20 During HAART Interruption
A Phase 2 study testing T-20 in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infection
- What is being tested?
- T-20
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to Apr 2003
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documentation of HIV-1 infection by licensed ELISA test kit and confirmed by a second method (e.g. Western Blot).
- Absolute CD4+ T-cell count of greater than or equal to 300/mm(3) within 30 days before randomization (For patients who are status post-splenectomy, also CD4+ T-cell greater than 20 percent)
- Receiving HAART (at least an NNRTI or a PI and at least 3 drugs) with at least 1 viral load test below the limit of detection (at least less than 500 copies/ml) greater than or equal to 3 months before screening.
- Stable HAART regimen greater than or equal to 1 month.
- Two confirmatory viral loads of less than 50 copies/ml prior to enrollment.
- Age at least 18 years.
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- For women of childbearing potential, a negative pregnancy test (serum or urine) is required within 14 days prior to treatment assignment.
- Ability to inject, or willingness to have injected by another person, T20 as required by protocol.
- Laboratory values (within 30 days prior to randomization):
- AST no more than 5 x the upper limit of normal (ULN).
- Total or direct bilirubin no more than 2 times ULN unless there is a pattern consistent with Gilbert's syndrome or the patient is receiving indinavir.
- Creatinine no more than 2.0 mg/dL.
- Platelet count at least 50,000/microliters.
- Willingness to provide blood samples for storage that may be used in future studies of HIV infection and/or immunopathogenesis.
Who cannot join
- Concurrent malignancy, or any other disease state, requiring cytotoxic chemotherapy.
- Symptomatic for significant HIV-related illnesses, such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma.
- A history of receiving both an NNRTI and a PI.
- Use of experimental, unlicensed antiretrovirals less than or equal to 6 months prior to enrollment. An exception may be made for hydroxyurea according to the judgement of the Principal Investigator.
- Current use of IL-2 or abacavir or prior participation in a HAART interruption study.
- Pregnancy or breastfeeding during study period.
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- Significant cardiac, pulmonary, kidney, rheumatologic, gastrointestinal, or CNS disease as detectable on routine history, physical examination , or screening laboratory studies.
- Psychiatric illness that, in the opinion of the PI, might interfere with study compliance.
- Active substance abuse or history of prior substance abuse that may interfere with protocol compliance or compromise patient safety.
- Refusal to practice safe sex or use precautions against pregnancy (effective birth control or abstinence).
- Known history or laboratory evidence of chronic hepatitis B infection requiring 3TC for control including surface antigen positivity.
- Receiving salvage HAART, i.e. evidence of clinical resistance to licensed antiretrovirals.
- Individuals accepted into the protocol who subsequently violate exclusion criteria 7-9 will be offered further counseling and psychiatric evaluation if indicated. If the situation is not resolved within a reasonable period of time, the PI, in consultation with the care team, may terminate subject participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study to Evaluate the Ability of Maintenance Therapy With the HIV Fusion Inhibitor T20 to Prevent Rebound of Plasma HIV RNA Following an Interruption of HAART
This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of the viral infection towards AIDS. However, this treatment is not problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to because of the many pills and capsules that must be taken daily. When patients stop taking HAART, their viral levels climb again. This study will see if T-20 can prolong the time it takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may provide insight into possible new HAART-sparing treatments.
HIV-infected patients 18 years of age and older who have received HAART for at least 1 month may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG).
Read more
Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients will then be evaluated once a month until their viral level is less than 50. The final clinic visit will be one month after this time.
In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and possibly again when they restart HAART and at the end of the study. For this procedure, whole blood is collected through a needle placed in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. The white cells are used to study T cell function and levels and to detect hidden virus.
Read the detailed description
Although highly active antiretroviral therapy (HAART) effectively suppresses HIV replication, it is now clear that it cannot completely eradicate HIV from infected individuals. We have also recently begun to appreciate more fully the scope of toxicities and inconveniences associated with HAART medications leading to difficulties with adherence. Thus, long-term use of HAART may be problematic in many HIV-infected individuals. These realizations have led to a search for strategies to shift the focus from eradication to suppression of HIV replication while reducing toxicity and enhancing compliance. One approach to achieve these goals is to attempt to find strategies that allow for prolonged periods off HAART medications. Recently, Trimeris corporation has developed T-20, an inhibitor of HIV fusion to T-cells, a step required to spread virus from cell to cell. This new class of therapy, which has little recognized toxicity, could be used to allow patients to discontinue HAART medications for prolonged periods of time. In this intent to treat pilot study, we propose to evaluate the ability of T-20 to slow or prevent rebound of plasma HIV RNA when HAART medications are interrupted for a single 6 week period. The information obtained through this investigation could provide important insights into novel therapeutic strategies for HIV infection.
- Conditions
- HIV Infection
- Being tested
- T-20
- Keywords
- HIV, T20, HAART, Interruption, Therapy, Fusion Inhibitor T20, Treatment Interuption
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-20Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2001 (estimated)
- Study startMar 2001
- Study completionApr 2003
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 InfectionStudies 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
- Treatment
- Enrolment
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013884
- Sponsor's protocol ID
- 010133
- Other IDs
- 01-I-0133
- Status last verified
- Apr 2003
- First submitted
- 31 Mar 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Zhang L, Ramratnam B, Tenner-Racz K, He Y, Vesanen M, Lewin S, Talal A, Racz P, Perelson AS, Korber BT, Markowitz M, Ho DD. Quantifying residual HIV-1 replication in patients receiving combination antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1605-13. doi: 10.1056/NEJM199905273402101.
PubMed 10341272Furtado MR, Callaway DS, Phair JP, Kunstman KJ, Stanton JL, Macken CA, Perelson AS, Wolinsky SM. Persistence of HIV-1 transcription in peripheral-blood mononuclear cells in patients receiving potent antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1614-22. doi: 10.1056/NEJM199905273402102.
PubMed 10341273Natarajan V, Bosche M, Metcalf JA, Ward DJ, Lane HC, Kovacs JA. HIV-1 replication in patients with undetectable plasma virus receiving HAART. Highly active antiretroviral therapy. Lancet. 1999 Jan 9;353(9147):119-20. doi: 10.1016/s0140-6736(05)76156-0. No abstract available.
PubMed 10023903
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Ability of Maintenance Therapy With the HIV Fusion Inhibitor T20 to Prevent Rebound of Plasma HIV RNA Following an Interruption of HAART
- ClinicalTrials.gov ID
- NCT00013884
- Acronym / sponsor ID
- 010133
- Conditions
- HIV Infection
- Keywords
- HIV, T20, HAART, Interruption, Therapy, Fusion Inhibitor T20, Treatment Interuption
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Apr 2003
- First posted
- 2 Apr 2001 (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.
This study will evaluate whether a drug called T-20 can slow or prevent a rapid return of HIV in the blood when HAART (highly active antiretroviral therapy) is stopped temporarily. HAART is a multi-dose regimen that is very effective in suppressing HIV and perhaps slowing or halting progression of the viral infection towards AIDS. However, this treatment is not problem-oriented. It cannot completely rid the body of virus, and long-term therapy carries a risk of toxicity (harmful side effects). Moreover, the treatment is difficult to adhere to because of the many pills and capsules that must be taken daily. When patients stop taking HAART, their viral levels climb again. This study will see if T-20 can prolong the time it takes for HIV blood levels to rise in patients who stop HAART temporarily. The results may provide insight into possible new HAART-sparing treatments.
HIV-infected patients 18 years of age and older who have received HAART for at least 1 month may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood and urine tests and possibly a chest X-ray and electrocardiogram (EKG).
Participants will receive either 100 Mg. of T-20 twice a day or 200 Mg. once a day, injected under the skin, and their normal HAART regimen for 3 days. (Patients or a caregiver will be taught how to give the T-20 injections.) On the fourth day, HAART will be stopped and all patients will receive 100 Mg. of T-20 twice a day for 6 weeks. Blood will be drawn weekly from the second to the sixth week after stopping HAART to check viral levels and CD4+ T cell counts. At the end of the 6 weeks, T-20 will be stopped and HAART will be restarted. Patients will then be evaluated once a month until their viral level is less than 50. The final clinic visit will be one month after this time.
In addition to blood draws, patients will undergo leukapheresis before beginning T-20 and possibly again when they restart HAART and at the end of the study. For this procedure, whole blood is collected through a needle placed in an arm vein, similar to donating blood. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the red cells, platelets and plasma are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. The white cells are used to study T cell function and levels and to detect hidden virus.
Detailed description
Although highly active antiretroviral therapy (HAART) effectively suppresses HIV replication, it is now clear that it cannot completely eradicate HIV from infected individuals. We have also recently begun to appreciate more fully the scope of toxicities and inconveniences associated with HAART medications leading to difficulties with adherence. Thus, long-term use of HAART may be problematic in many HIV-infected individuals. These realizations have led to a search for strategies to shift the focus from eradication to suppression of HIV replication while reducing toxicity and enhancing compliance. One approach to achieve these goals is to attempt to find strategies that allow for prolonged periods off HAART medications. Recently, Trimeris corporation has developed T-20, an inhibitor of HIV fusion to T-cells, a step required to spread virus from cell to cell. This new class of therapy, which has little recognized toxicity, could be used to allow patients to discontinue HAART medications for prolonged periods of time. In this intent to treat pilot study, we propose to evaluate the ability of T-20 to slow or prevent rebound of plasma HIV RNA when HAART medications are interrupted for a single 6 week period. The information obtained through this investigation could provide important insights into novel therapeutic strategies for HIV infection.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Documentation of HIV-1 infection by licensed ELISA test kit and confirmed by a second method (e.g. Western Blot).
- Absolute CD4+ T-cell count of greater than or equal to 300/mm(3) within 30 days before randomization (For patients who are status post-splenectomy, also CD4+ T-cell greater than 20 percent)
- Receiving HAART (at least an NNRTI or a PI and at least 3 drugs) with at least 1 viral load test below the limit of detection (at least less than 500 copies/ml) greater than or equal to 3 months before screening.
- Stable HAART regimen greater than or equal to 1 month.
- Two confirmatory viral loads of less than 50 copies/ml prior to enrollment.
Key exclusion criteria (13 listed)
- Concurrent malignancy, or any other disease state, requiring cytotoxic chemotherapy.
- Symptomatic for significant HIV-related illnesses, such as opportunistic infections and malignancies other than mucocutaneous Kaposi's sarcoma.
- A history of receiving both an NNRTI and a PI.
- Use of experimental, unlicensed antiretrovirals less than or equal to 6 months prior to enrollment. An exception may be made for hydroxyurea according to the judgement of the Principal Investigator.
- Current use of IL-2 or abacavir or prior participation in a HAART interruption study.
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 |
|---|---|---|
| T-20 | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 10341272Zhang L, Ramratnam B, Tenner-Racz K, He Y, Vesanen M, Lewin S, Talal A, Racz P, Perelson AS, Korber BT, Markowitz M, Ho DD. Quantifying residual HIV-1 replication in patients receiving combination antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1605-13. doi: 10.1056/NEJM199905273402101.
- Background: PubMed 10341273Furtado MR, Callaway DS, Phair JP, Kunstman KJ, Stanton JL, Macken CA, Perelson AS, Wolinsky SM. Persistence of HIV-1 transcription in peripheral-blood mononuclear cells in patients receiving potent antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1614-22. doi: 10.1056/NEJM199905273402102.
- Background: PubMed 10023903Natarajan V, Bosche M, Metcalf JA, Ward DJ, Lane HC, Kovacs JA. HIV-1 replication in patients with undetectable plasma virus receiving HAART. Highly active antiretroviral therapy. Lancet. 1999 Jan 9;353(9147):119-20. doi: 10.1016/s0140-6736(05)76156-0. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing T-20 in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 14 inclusion and 13 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 4 Mar 2008. 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 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00013884, 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 4 Mar 2008.