HIV InfectionsPhase 2NCT00001087
The Effectiveness of Nelfinavir and Efavirenz, Used Alone or Together, Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
A Phase 2 study testing Ritonavir, Nelfinavir mesylate and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
Trial summary
Steps I and II: The purpose of this study is the following: To look at how many patients achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood levels from the beginning of the study to Week 16. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Ritonavir, Nelfinavir mesylate and Efavirenz
- How many people
- 300 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Start not givento Jul 2000
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Required:
- Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 count of 200 cells/mm3 or less.
- Allowed:
- Topical and oral antifungal except for oral ketoconazole.
- Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated.
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- All antibiotics as clinically indicated.
- Systemic corticosteroid use for no more than 21 days for acute problems as medically indicated. Note: Steroid use for more than 21 days is considered on a case-by-case basis.
- Recombinant erythropoietin (rEPO) and granulocyte colony-stimulating factor (G-CSF) as medically indicated.
- Regularly prescribed medications such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate, testosterone, or any other medications as medically indicated.
- [AS PER AMENDMENT 4/25/00:
- Allowed with caution:
- Pentamidine, allopurinol, hydroxyurea. Use of these medications may increase exposure to ddI.]
- Concurrent Treatment:
- Allowed:
- Dependency of less than 3 units of blood per 21-day period.
- Alternative therapies such as acupuncture and visualization techniques.
- Patients must have:
- HIV infection documented by a licensed ELISA and confirmed by Western blot, positive HIV culture, positive HIV antigen, positive plasma HIV RNA, or second antibody test positive by a method other than ELISA. Repeat HIV-antibody testing is not required for enrollment in this trial (implicit in patients having been enrolled in ACTG 302/303).
- Signed, informed consent from parent or legal guardian for patients under 18 years of age.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Inability to tolerate ddI at 200-400 mg/day, 3TC at 300 mg/day, or d4T at 60-80 mg/day, with intolerance defined as recurrent toxicities requiring dose interruptions and reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).
- Grade 2 or higher peripheral neuropathy.
- Malignancy requiring systemic therapy.
- Co-enrollment in other antiretroviral protocols; co-enrollment in other ACTG protocols is encouraged, particularly those involving prophylaxis for opportunistic infections.
Show all 29Show fewer
- Concurrent Medication:
- Excluded:
- All antiretroviral therapies other than study medications.
- Investigational drugs and vaccines without specific approval from the Protocol Chair/Vice Chairs.
- Systemic cytotoxic chemotherapy.
- Interferon, interleukins, GM-CSF, and HIV-1 vaccines.
- Rifabutin and rifampin.
- Ketoconazole, astemizole, cisapride, midazolam, terfenadine, and triazolam.
- Acute therapy for an infection or other medical illness.
- Herbal medications.
- Vitamins. [10. AS PER AMENDMENT 3/5/98:
- Ergot alkaloids or drugs containing derivatives or ergot alkaloids.]
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Prior Medication:
- Excluded:
- PIs.
- NNRTIs.
- Acute therapy for an infection or other medical illness within 14 days prior to the time of study entry.
- Chronic long-term steroid use is not permitted unless it is within physiologic replacement levels; protocol chair/vice chairs must be contacted in these instances.
- Risk Behavior:
- Excluded:
- Current ethanol abuse by personal history or a report from a primary physician.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Northwestern University CRS
Chicago, Illinois, 60611
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612
NY Univ. HIV/AIDS CRS
New York, New York
About this study
Official title: Comparison of the Virologic Efficacy of Nelfinavir and/or DMP 266 (Efavirenz, EFV) in Combination With One or Two New Nucleoside Analogs in Nucleoside Experienced Subjects: A Roll-Over Study to ACTG 302/303
Steps I and II: The purpose of this study is the following: To look at how many patients achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood levels from the beginning of the study to Week 16. To look at the safety and tolerability of nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately in regimens containing reverse transcriptase inhibitors (RTIs). For the 2 extension studies (Weeks 49 to 144): To look at the proportion of patients whose long-term viral load remains undetectable at Week 96. To look at the time from the beginning of the study to treatment failure, with patients evaluated through Week 144. Step III: To look at the proportion of patients whose HIV blood levels are undetectable 16 weeks after starting the salvage study treatment. To assess safety, toxicity, and tolerance of salvage study drug treatment. (This study has been changed by adding new objectives.) Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy. However, there are few established guidelines for devising combinations of different classes of drugs which will enhance the potential for achieving viral suppression, reducing the risk of toxicity, and preserving therapeutic options for future use. This study includes 2 anti-HIV drugs, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with RTI therapy for the purpose of limiting HIV replication. Patients with treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies: 2-drug PI regimen (saquinavir and ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved anti-HIV drugs outside the study; or the best available treatment outside the study. The new RTI, adefovir dipivoxil, is added to the 2-drug PI regimen to achieve suppression of viral replication and thereby delay disease progression. (This rationale reflects a change in the treatment given to patients with treatment failure at Week 16.)
Read the detailed description
Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy, yet there are few established guidelines to provide the framework by which to devise combinations of different classes of drugs which will not only enhance the potential for achieving viral suppression while reducing the risk of toxicity but will also preserve therapeutic options for future use. This study includes 2 antiretroviral compounds, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with reverse transcriptase inhibitor (RTI) therapy for the purpose of limiting HIV replication. [AS PER AMENDMENT 3/5/98: Patients who experience treatment failure at Week 16 or later choose 1 of the following alternative potent salvage therapy regimens: a dual-PI regimen (saquinavir/ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved antiretroviral drugs outside the study; or the best available treatment outside the study. The new reverse transcriptase inhibitor, adefovir dipivoxil, is added to the dual-PI regimen to achieve suppression of viral replication and thereby delay disease progression.]
Step I: Patients with detectable plasma HIV RNA levels are assigned to Group A, and those with undetectable levels are assigned to Group B (control).
Group A: Patients are randomized to 1 of 3 treatment arms: NFV plus EFV placebo on Arm I; NFV placebo plus EFV on Arm II; or NFV plus EFV on Arm III. Concurrent with their randomly assigned therapy, patients receive open-label RTI therapy comprising 1 of the following 3 combinations that provides 1 or 2 new RTIs: didanosine (ddI) plus stavudine (d4T); lamivudine (3TC) plus d4T; or ddI plus 3TC. [AS PER AMENDMENT 12/02/97: Patients with virologic failure at Week 16 seek the best available therapy outside the study or continue study medication for up to 120 days.] [AS PER AMENDMENT 3/5/98: Patients with virologic failure at Week 16 now proceed to Step III.] Patients without virologic failure continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 3/5/98: and those without virologic failure at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: After Week 96, patients in Arm I may switch to Arm III or seek the best available antiretroviral therapy outside the study. Patients in Arm II or III with undetectable plasma HIV RNA levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study) or seek the best alternative antiretroviral therapy. Patients in Arm II or III with detectable plasma HIV RNA levels but without virologic failure at Week 48 continue their current study therapy or proceed to Step III. Patients with confirmed virologic failure at Week 48 or later proceed to Step III or seek the best available alternative therapy outside the study.] Group B: Patients receive treatment on their assigned, open-label ACTG 302/303 regimen. Patients with detectable plasma HIV RNA levels discontinue Group B therapy and proceed to Step II. Patients with undetectable plasma HIV RNA levels continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 6/24/98: and those with undetectable levels at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: Patients with undetectable levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study).] Step II: Patients receive treatment as in Group A. [Step III: AS PER AMENDMENT 3/5/98: Patients choose 1 of 3 alternative therapies: saquinavir soft gel capsule, ritonavir, adefovir dipivoxil, and L-carnitine on Arm X; EFV or NFV plus 2 new approved antiretroviral drugs outside the study on Arm Y (if no prior EFV or NFV); or best available medication outside the study on Arm Z.
Patients in Arm X or Y are followed on salvage therapy for 24 to 48 weeks. Patients with detectable plasma HIV RNA levels after 16 weeks on salvage therapy are encouraged to discontinue study medication and seek best alternative treatment.]
- Conditions
- HIV Infections
- Being tested
- Ritonavir, Nelfinavir mesylate, Efavirenz, Levocarnitine, Adefovir dipivoxil
- Keywords
- Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Ritonavir, Saquinavir, Nelfinavir, Reverse Transcriptase Inhibitors, Adenine, Anti-HIV Agents, efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitonavirDrug
Nelfinavir mesylateDrug
EfavirenzDrug
LevocarnitineDrug
Adefovir dipivoxilDrug
SaquinavirDrug
LamivudineDrug
StavudineDrug
ZidovudineDrug
ZalcitabineDrug
DidanosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary Albrecht, Study chairDavid Katzenstein, Study chairScott Hammer, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001087
- Sponsor's protocol ID
- ACTG 364
- Other IDs
- 10691
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Albrecht MA, Bosch RJ, Hammer SM, Liou SH, Kessler H, Para MF, Eron J, Valdez H, Dehlinger M, Katzenstein DA; AIDS Clinical Trials Group 364 Study Team. Nelfinavir, efavirenz, or both after the failure of nucleoside treatment of HIV infection. N Engl J Med. 2001 Aug 9;345(6):398-407. doi: 10.1056/NEJM200108093450602.
PubMed 11496850Albrecht M, Hammer S, Liou S, Bosch R, Katzenstein D. Long-term virologic and immune responses in subjects maintained on exclusive nucleoside analog (NRTI)based therapy in ACTG 364. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 322)
Katzenstein DA, Bosch RJ, Hellmann N, Wang N, Bacheler L, Albrecht MA; ACTG 364 Study Team. Phenotypic susceptibility and virological outcome in nucleoside-experienced patients receiving three or four antiretroviral drugs. AIDS. 2003 Apr 11;17(6):821-30. doi: 10.1097/00002030-200304110-00007.
PubMed 12660529Winters MA, Bosch RJ, Albrecht MA, Katzenstein DA; AIDS Clinical Trials Group 364 Study Team. Clinical impact of the M184V mutation on switching to didanosine or maintaining lamivudine treatment in nucleoside reverse-transcriptase inhibitor-experienced patients. J Infect Dis. 2003 Aug 15;188(4):537-40. doi: 10.1086/377742. Epub 2003 Jul 24.
PubMed 12898440Bosch RJ, Downey GF, Katzenstein DA, Hellmann N, Bacheler L, Albrecht MA; ACTG 364 Study Team. Evaluation of cutpoints for phenotypic hypersusceptibility to efavirenz. AIDS. 2003 Nov 7;17(16):2395-6. doi: 10.1097/00002030-200311070-00016. No abstract available.
PubMed 14571193
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Virologic Efficacy of Nelfinavir and/or DMP 266 (Efavirenz, EFV) in Combination With One or Two New Nucleoside Analogs in Nucleoside Experienced Subjects: A Roll-Over Study to ACTG 302/303
- ClinicalTrials.gov ID
- NCT00001087
- Acronym / sponsor ID
- ACTG 364
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Ritonavir, Saquinavir, Nelfinavir, Reverse Transcriptase Inhibitors, Adenine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2000 (actual)
- First posted
- 31 Aug 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.
Steps I and II: The purpose of this study is the following: To look at how many patients achieve undetectable HIV blood levels at Week 16. To look at the absolute change in HIV blood levels from the beginning of the study to Week 16. To look at the safety and tolerability of nelfinavir (NFV) and efavirenz (EFV) when used in combination or separately in regimens containing reverse transcriptase inhibitors (RTIs). For the 2 extension studies (Weeks 49 to 144): To look at the proportion of patients whose long-term viral load remains undetectable at Week 96. To look at the time from the beginning of the study to treatment failure, with patients evaluated through Week 144. Step III: To look at the proportion of patients whose HIV blood levels are undetectable 16 weeks after starting the salvage study treatment. To assess safety, toxicity, and tolerance of salvage study drug treatment. (This study has been changed by adding new objectives.) Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy. However, there are few established guidelines for devising combinations of different classes of drugs which will enhance the potential for achieving viral suppression, reducing the risk of toxicity, and preserving therapeutic options for future use. This study includes 2 anti-HIV drugs, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with RTI therapy for the purpose of limiting HIV replication. Patients with treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies: 2-drug PI regimen (saquinavir and ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved anti-HIV drugs outside the study; or the best available treatment outside the study. The new RTI, adefovir dipivoxil, is added to the 2-drug PI regimen to achieve suppression of viral replication and thereby delay disease progression. (This rationale reflects a change in the treatment given to patients with treatment failure at Week 16.)
Detailed description
Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy, yet there are few established guidelines to provide the framework by which to devise combinations of different classes of drugs which will not only enhance the potential for achieving viral suppression while reducing the risk of toxicity but will also preserve therapeutic options for future use. This study includes 2 antiretroviral compounds, NFV (a protease inhibitor [PI]) and EFV (a nonnucleoside reverse transcriptase inhibitor [NNRTI]), for use either alone or in combination with reverse transcriptase inhibitor (RTI) therapy for the purpose of limiting HIV replication. [AS PER AMENDMENT 3/5/98: Patients who experience treatment failure at Week 16 or later choose 1 of the following alternative potent salvage therapy regimens: a dual-PI regimen (saquinavir/ritonavir) plus adefovir dipivoxil and L-carnitine; EFV or NFV (if not already given) plus 2 new approved antiretroviral drugs outside the study; or the best available treatment outside the study. The new reverse transcriptase inhibitor, adefovir dipivoxil, is added to the dual-PI regimen to achieve suppression of viral replication and thereby delay disease progression.]
Step I: Patients with detectable plasma HIV RNA levels are assigned to Group A, and those with undetectable levels are assigned to Group B (control).
Group A: Patients are randomized to 1 of 3 treatment arms: NFV plus EFV placebo on Arm I; NFV placebo plus EFV on Arm II; or NFV plus EFV on Arm III. Concurrent with their randomly assigned therapy, patients receive open-label RTI therapy comprising 1 of the following 3 combinations that provides 1 or 2 new RTIs: didanosine (ddI) plus stavudine (d4T); lamivudine (3TC) plus d4T; or ddI plus 3TC. [AS PER AMENDMENT 12/02/97: Patients with virologic failure at Week 16 seek the best available therapy outside the study or continue study medication for up to 120 days.] [AS PER AMENDMENT 3/5/98: Patients with virologic failure at Week 16 now proceed to Step III.] Patients without virologic failure continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 3/5/98: and those without virologic failure at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: After Week 96, patients in Arm I may switch to Arm III or seek the best available antiretroviral therapy outside the study. Patients in Arm II or III with undetectable plasma HIV RNA levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study) or seek the best alternative antiretroviral therapy. Patients in Arm II or III with detectable plasma HIV RNA levels but without virologic failure at Week 48 continue their current study therapy or proceed to Step III. Patients with confirmed virologic failure at Week 48 or later proceed to Step III or seek the best available alternative therapy outside the study.] Group B: Patients receive treatment on their assigned, open-label ACTG 302/303 regimen. Patients with detectable plasma HIV RNA levels discontinue Group B therapy and proceed to Step II. Patients with undetectable plasma HIV RNA levels continue therapy during Weeks 1 to 48 [AS PER AMENDMENT 6/24/98: and those with undetectable levels at Week 48 may continue therapy during Weeks 49 to 96 (first extension study)]. [AS PER AMENDMENT 5/27/99: Patients with undetectable levels at Week 96 may continue therapy during Weeks 97 to 144 (second extension study).] Step II: Patients receive treatment as in Group A. [Step III: AS PER AMENDMENT 3/5/98: Patients choose 1 of 3 alternative therapies: saquinavir soft gel capsule, ritonavir, adefovir dipivoxil, and L-carnitine on Arm X; EFV or NFV plus 2 new approved antiretroviral drugs outside the study on Arm Y (if no prior EFV or NFV); or best available medication outside the study on Arm Z.
Patients in Arm X or Y are followed on salvage therapy for 24 to 48 weeks. Patients with detectable plasma HIV RNA levels after 16 weeks on salvage therapy are encouraged to discontinue study medication and seek best alternative treatment.]
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Chemoprophylaxis for Pneumocystis carinii pneumonia for all patients who have a CD4 count of 200 cells/mm3 or less.
- Topical and oral antifungal except for oral ketoconazole.
- Treatment, maintenance, or chemoprophylaxis with approved agents for opportunistic infections as clinically indicated.
- All antibiotics as clinically indicated.
- Systemic corticosteroid use for no more than 21 days for acute problems as medically indicated. Note: Steroid use for more than 21 days is considered on a case-by-case basis.
Key exclusion criteria (29 listed)
- Inability to tolerate ddI at 200-400 mg/day, 3TC at 300 mg/day, or d4T at 60-80 mg/day, with intolerance defined as recurrent toxicities requiring dose interruptions and reductions or permanent discontinuation of the drugs (other than Grade 3 or 4 anemia).
- Grade 2 or higher peripheral neuropathy.
- Malignancy requiring systemic therapy.
- Co-enrollment in other antiretroviral protocols; co-enrollment in other ACTG protocols is encouraged, particularly those involving prophylaxis for opportunistic infections.
- All antiretroviral therapies other than study medications.
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 |
|---|---|---|
| Ritonavir | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Efavirenz | Drug | – |
| Levocarnitine | Drug | – |
| Adefovir dipivoxil | Drug | – |
| Saquinavir | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | Drug | – |
| Zidovudine | Drug | – |
| Zalcitabine | Drug | – |
| Didanosine | 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 1 Nov 2021.
- Background: PubMed 11496850Albrecht MA, Bosch RJ, Hammer SM, Liou SH, Kessler H, Para MF, Eron J, Valdez H, Dehlinger M, Katzenstein DA; AIDS Clinical Trials Group 364 Study Team. Nelfinavir, efavirenz, or both after the failure of nucleoside treatment of HIV infection. N Engl J Med. 2001 Aug 9;345(6):398-407. doi: 10.1056/NEJM200108093450602.
- BackgroundAlbrecht M, Hammer S, Liou S, Bosch R, Katzenstein D. Long-term virologic and immune responses in subjects maintained on exclusive nucleoside analog (NRTI)based therapy in ACTG 364. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 322)
- Background: PubMed 12660529Katzenstein DA, Bosch RJ, Hellmann N, Wang N, Bacheler L, Albrecht MA; ACTG 364 Study Team. Phenotypic susceptibility and virological outcome in nucleoside-experienced patients receiving three or four antiretroviral drugs. AIDS. 2003 Apr 11;17(6):821-30. doi: 10.1097/00002030-200304110-00007.
- Background: PubMed 12898440Winters MA, Bosch RJ, Albrecht MA, Katzenstein DA; AIDS Clinical Trials Group 364 Study Team. Clinical impact of the M184V mutation on switching to didanosine or maintaining lamivudine treatment in nucleoside reverse-transcriptase inhibitor-experienced patients. J Infect Dis. 2003 Aug 15;188(4):537-40. doi: 10.1086/377742. Epub 2003 Jul 24.
- Background: PubMed 14571193Bosch RJ, Downey GF, Katzenstein DA, Hellmann N, Bacheler L, Albrecht MA; ACTG 364 Study Team. Evaluation of cutpoints for phenotypic hypersusceptibility to efavirenz. AIDS. 2003 Nov 7;17(16):2395-6. doi: 10.1097/00002030-200311070-00016. 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.
Mary Albrecht study chair
David Katzenstein study chair
Scott Hammer study chair
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritonavir, Nelfinavir mesylate and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 20 inclusion and 29 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Puerto Rico. 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 NCT00001087, 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 1 Nov 2021.