HIV InfectionsNCT00002407
A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs
A study testing Indinavir sulfate, Nevirapine and Lamivudine in people with HIV Infections, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Nevirapine and Lamivudine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- Diagnosed asymptomatic HIV infection.
- HIV-1 RNA greater than 500 copies/ml.
- CD4+ T-cell count greater than 200/mm3.
- Never received antiretroviral therapy.
Who cannot join
- Co-existing Condition:
- Excluded:
- Severe non-HIV-related disease.
- Patients with the following prior conditions are excluded:
- History of neuropathy.
- Prior Medication:
Show all 13Show fewer
- Excluded:
- Investigational drug within 1 month prior to study.
- Immunomodulatory drug within 1 month prior to study.
- Prior Treatment:
- Excluded:
- Radiation therapy within past month.
- Chemotherapy within past month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cornell AIDS Clinical Trials Unit
New York, New York, 10021
About this study
Official title: A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3
The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.
Read the detailed description
In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:
Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Nevirapine, Lamivudine, Stavudine, Didanosine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indinavir sulfateDrug
NevirapineDrug
LamivudineDrug
StavudineDrug
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Weill Medical College of Cornell UniversityThe 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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002407
- Sponsor's protocol ID
- ATLANTIC STUDY
- Status last verified
- Nov 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Katlama C, Murphy R, Johnson V, Squires K, Horban A, Gatell J, Clotet B, Staszewski S, VanLeeuwen R, Clumeck N, Moroni M, Pavia A, Schmidt Au Gonzalez-Lahoz J, Antunes F, Gulick R, Banhegyi D, Montaner J, Calvez V, Sommadossi JP, Lange J. The Atlantic study: a randomised open-label study comparing two protease inhibitors (PI)-sparing antiretroviral strategies versus a standard PI-containing regimen. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:70 (abstract no 18)
Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10.
PubMed 11366117Douglas J. Ward, MD. Lipodystrophy Substudy of Atlantic Trial Offers Limited Insights. http://www.medscape.com/viewarticle/438301
Murphy RL, Katlama C, Weverling GJ, et al. Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study. Program and abstracts of the XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain. Abstract WeOrB1306.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3
- ClinicalTrials.gov ID
- NCT00002407
- Acronym / sponsor ID
- ATLANTIC STUDY
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- 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.
The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.
Detailed description
In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens:
Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed asymptomatic HIV infection.
- HIV-1 RNA greater than 500 copies/ml.
- CD4+ T-cell count greater than 200/mm3.
- Never received antiretroviral therapy.
Key exclusion criteria (13 listed)
- Severe non-HIV-related disease.
- History of neuropathy.
- Investigational drug within 1 month prior to study.
- Immunomodulatory drug within 1 month prior to study.
- Radiation therapy within past month.
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Nevirapine | Drug | – |
| Lamivudine | Drug | – |
| Stavudine | 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 24 Jun 2005.
- BackgroundKatlama C, Murphy R, Johnson V, Squires K, Horban A, Gatell J, Clotet B, Staszewski S, VanLeeuwen R, Clumeck N, Moroni M, Pavia A, Schmidt Au Gonzalez-Lahoz J, Antunes F, Gulick R, Banhegyi D, Montaner J, Calvez V, Sommadossi JP, Lange J. The Atlantic study: a randomised open-label study comparing two protease inhibitors (PI)-sparing antiretroviral strategies versus a standard PI-containing regimen. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:70 (abstract no 18)
- Background: PubMed 11366117Norton M. Choosing the right initial antiretroviral regimens. GMHC Treat Issues. 1999 Feb;13(2):7-10.
- BackgroundDouglas J. Ward, MD. Lipodystrophy Substudy of Atlantic Trial Offers Limited Insights. http://www.medscape.com/viewarticle/438301
- BackgroundMurphy RL, Katlama C, Weverling GJ, et al. Fat redistribution and metabolic changes with a nucleoside-reverse transcriptase inhibitor (NRTI), non-NRTI, or protease inhibitor-based regimen: FRAMS substudy of the Atlantic study. Program and abstracts of the XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain. Abstract WeOrB1306.
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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 study testing Indinavir sulfate, Nevirapine and Lamivudine in people with HIV Infections, run by Weill Medical College of Cornell University 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 5 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 24 Jun 2005. 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.
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 NCT00002407, which also lists 4 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 24 Jun 2005.