HIV InfectionsPhase 3NCT00006397
Differences Between Women and Men Taking a Combination of Indinavir, Ritonavir, Enteric-Coated Didanosine, and Stavudine Who Previously Took Anti-HIV Drugs
A Phase 3 study testing Indinavir sulfate, Ritonavir and Stavudine in people with HIV Infections, run by PPD Development, LP at 15 sites in 2 countries.
Trial summary
The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women. 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, Ritonavir and Stavudine
- How many people
- 200 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Aug 2000to not given
- Phase
- Phase 3
- 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 may be eligible for this study if they:
- Are HIV-positive.
- Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
- Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
- Failed to keep their viral load low during previous anti-HIV treatment.
- Are at least 18 years of age.
- Agree to use an effective barrier method of birth control.
Who cannot join
- Patients will not be eligible for this study if they:
- Have used a protease inhibitor for more than 14 days.
- Have used ddI or d4T for more than 30 days.
- Are pregnant or breast-feeding.
- Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
- Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
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- Are at risk for, or have had, pancreatitis (disease of the pancreas).
- Have difficulty absorbing medications.
- Have a cancer, other than Kaposi's sarcoma, that may require systemic treatment.
- Have any medical condition or treatment that may cause a rise in viral load.
- Have any other condition or previous treatment that would interfere with the study.
- Are unable to take drugs by mouth.
- Are receiving or have received recently any of the following drugs: terfenadine, astemizole, cisapride, triazolam, midazolam, ergot alkaloids, amiodarone, bepridil, flecainide, propafenone, quinidine, pimozide, rifampin, and intravenous (IV) pentamidine.
- Are receiving vincristine, thalidomide, foscarnet, or cisplatin or other medications that may cause nerve damage.
- Have received any experimental drug within 30 days prior to treatment.
- Are receiving treatment with testosterone, anabolic steroids, growth hormone, or megestrol acetate, except for certain hormonal problems.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
East Bay AIDS Ctr
Berkeley, California, 94705
JSI Research and Training Institute
Boston, Massachusetts, 02210
Univ of Texas Southwestern Med Ctr
Dallas, Texas, 75390
North Broward Hosp District / HIV Clinical Research
Fort Lauderdale, Florida, 33311
Univ of Southern California
Los Angeles, California, 90033
UCLA CARE Ctr
Los Angeles, California, 90095
Vanderbilt Univ School of Medicine
Nashville, Tennessee, 37212
Louisiana State Univ Med Ctr / HIV Outpatient Clinic
New Orleans, Louisiana, 70112
Beth Israel Med Ctr
New York, New York, 10003
Harlem Hosp Ctr
New York, New York, 10037
Univ of Med & Dentistry of New Jersey
Newark, New Jersey, 07103
Univ of Rochester Med Ctr
Rochester, New York, 14642
Saint Josephs Comprehensive Research Institute
Tampa, Florida, 33607
Puerto Rico2 sites
Ponce Univ Hosp
Ponce, 00731
Univ of Puerto Rico School of Med
Rio Piedras, 00935
About this study
Official title: A Study of the Combination of Indinavir, Ritonavir, Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients: An Open-Label Study Investigating Differences Between Women and Men
The purpose of this study is to see how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.
Read the detailed description
Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Ritonavir, Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Sex Factors, Ritonavir, Indinavir, Dosage Forms, Reverse Transcriptase Inhibitors, Anti-HIV Agents
- 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
RitonavirDrug
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)
- Study startAug 2000
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.
- 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 3
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- PPD Development, LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006397
- Sponsor's protocol ID
- 312A
- Other IDs
- BMS 2000
- Status last verified
- Jun 2001
- First submitted
- 10 Oct 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
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 Study of the Combination of Indinavir, Ritonavir, Enteric-Coated ddI and d4T In Nucleoside and Non-Nucleoside Reverse Transcriptase Inhibitor Experienced Patients: An Open-Label Study Investigating Differences Between Women and Men
- ClinicalTrials.gov ID
- NCT00006397
- Acronym / sponsor ID
- 312A
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Sex Factors, Ritonavir, Indinavir, Dosage Forms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- PPD Development, LPIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- 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 how safe and effective it is to give multi-drug treatment with indinavir (IDV) plus ritonavir (RTV) plus enteric-coated didanosine (ddI) plus stavudine (d4T) and if there are differences in responses between men and women.
Detailed description
Patients are enrolled in balanced numbers based on gender and stratified by viral load (less than or equal to 10,000, 10,000 to 100,000, or more than 100,000 copies/ml). Prior to therapy, a peer-based patient education intervention is presented. Patients receive a combination of IDV, RTV, enteric-coated ddI, and d4T. Responses to this multi-agent antiretroviral drug regimen are explored based on sex differences. A pharmacokinetic sub-study, balanced so that half of patients are male and half are female, is performed on IDV and RTV for 20 to 25 of the patients. About 20 females are examined for study-drug effects on gonadotropic hormone levels.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have viral load (amount of HIV in the blood) greater than 500 copies/ml.
- Have received anti-HIV treatment previously with an NNRTI plus an NRTI combination or only NRTIs for greater than 8 weeks and, if not currently on treatment, have been off treatment for 12 weeks or less.
- Failed to keep their viral load low during previous anti-HIV treatment.
- Are at least 18 years of age.
Key exclusion criteria (16 listed)
- Have used a protease inhibitor for more than 14 days.
- Have used ddI or d4T for more than 30 days.
- Are pregnant or breast-feeding.
- Have an opportunistic (AIDS-related) infection requiring treatment at the time of enrollment.
- Have, or appear to have, peripheral neuropathy (a painful condition affecting the nervous system) at the time of screening.
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 | – |
| Ritonavir | Drug | – |
| Stavudine | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indinavir sulfate, Ritonavir and Stavudine in people with HIV Infections, run by PPD Development, LP at 15 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 7 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: status not confirmed, 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 15 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
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.