HIV InfectionsPhase 2NCT00637572
Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss
A Phase 2 study testing Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL and Megestrol acetate oral suspension 40 mg/mL in people with HIV Infections and Cachexia, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in 3 countries.
Trial summary
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections, Cachexia, Anorexia
- What is being tested?
- Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL and Megestrol acetate oral suspension 40 mg/mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2004to Jun 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Capable of and willing to provide informed consent
- Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator)
- An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weight for frame size, or a recent history of unintentional weight loss of 10% from the subjects baseline
- Weight losses was clinically associated with AIDS-related wasting and not related to any other disease process
- Women of childbearing potential had to agree to use effective contraception for the duration of the study and for two weeks after the last dose
- Clinical laboratory values had to be within normal limits or out-of-range limits must be designated as not clinically significant (some exceptions per protocol)
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- Able to read and write in the study related documents translated into the primary local language
- Capable of and willing to return to the clinic regularly for study visits
- Must have been taking a stable regimen of accepted HIV anti-retroviral treatments for at least two weeks prior to study entry
- Capable of completing a 3-day food intake diary with instruction
- Willing to abstain from any illegal or recreational drug substances for the duration of the trial
- Willing to abstain from taking any other medications or substances known to affect appetite or weight gain (eg, steroids [other than those inhaled for treatment of asthmatic conditions], nutritional supplements [other than vitamins or minerals], dronabinol, recombinant human growth hormone, etc.)
Who cannot join
- Weight loss due to factors other than AIDS-related wasting
- Enrollment in any other clinical trial
- Lack of access to regular meals
- Women of childbearing potential could not be pregnant or nursing
- Clinically severe depression evidenced by a baseline score of 17 or more on the Hamilton Depression Rating Scale (GRID-HAMD-17)
- Recent evidence of or history of significant psychiatric illness that may have compromised the subject's ability to comply with the study requirements
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- Intractable or frequent vomiting that regularly interfered with eating
- Clinically significant diarrhea that would have interfered with absorption of foods or medications
- Clinically significant oral lesions or dental conditions that would have interfered with eating a regular diet
- History or evidence of thromboembolic events or any first degree relative with a history of thromboembolic events
- Active AIDS-defining illness or other clinically significant or uncontrolled medical problems
- Current evidence of or history of diabetes mellitus or hypoadrenalism
- Systemic treatment with glucocorticoids within the 12 months prior to study entry
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
South Africa7 sites
40 Arthur Hobbs Street
Boksburg, Johannesburg, 1466
Eastmed Hospital
Eastlynn, Pretoria, 0186
TrialTech Clinical Research
Hatfield, Pretoria, 0001
Quinta-research
Pellissier, Bloemfontein, 9317
St Mary's Hospital
Private Bag, Ashwood, 3605
6 Calypso Centre
Richards Bay, KwaZulu-Natal, 3900
Genclin Corporation, Clinical Trial Centre
Westdene, Bloemfontein, 9301
India4 sites
Victoria Hospital
Bangalore, Karnataka, 560002
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054
Kasturba Medical College
Mangalore, Karnataka, 575003
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, 411001
United States1 site
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
About this study
Official title: A Randomized, Open-labeled, Pilot Study Comparing Weight Gain in Adults With AIDS-related Wasting Given Either Megestrol Acetate Oral Suspension Nanocrystal Dispersion (MA-NCD) or Megestrol Acetate Oral Suspension (Megace)
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation
- Conditions
- HIV Infections, Cachexia, Anorexia, AIDS Wasting Syndrome, HIV Wasting Syndrome
- Being tested
- Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL, Megestrol acetate oral suspension 40 mg/mL
- Keywords
- Weight loss, Cachexia, Anorexia, Megestrol acetate oral suspension, Nanocrystal dispersion, Nanocrystal technology, Body weight changes, AIDS wasting, HIV wasting, Emaciation, Megace ES, Megace, Treatment Experienced
- Medical subject headings
- HIV Infections, Cachexia, Anorexia, HIV Wasting Syndrome, Weight Loss, Body Weight Changes, Emaciation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mLDrug
Also called Megace ES
Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose)
Megestrol acetate oral suspension 40 mg/mLDrug
Also called Megace
Megestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose)
| Study group | Role | What they receive |
|---|---|---|
| Megestrol acetate oral suspension nanocrystal dispersion | Experimental | Megestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL Receives: Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL |
| Megestrol acetate oral suspension micronized formulation | Active comparator | Megestrol acetate oral suspension micronized formulation 60 mg/mL Receives: Drug: Megestrol acetate oral suspension 40 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
Measured: Baseline (Day 1) to Week 12
Secondary outcomes (10)
Change From Baseline in Lean Mass
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Impedance
Electrical impedance is a method for body composition assessment. The procedure involves sending a small current through the body and measuring the resistance in ohm. High resistance is associated with smaller amounts of fat-free mass. Smaller resistance is associated with large amounts of fat-free mass.
Measured: Baseline (Day 1) to Week 12
Change From Baseline in Body Fat Mass
Measured: Baseline (Day 1) to Week 12
Change in Hip Circumference
Measured: Baseline (Day 1) to Week 12
Change in Waist Circumference
Measured: Baseline (Day 1) to Week 12
Change in Tricep Skinfold
Measured: Baseline (Day 1) to Week 12
Change in Mid-arm Circumference
Measured: Baseline (Day 1) to Week 12
Change in Total Energy
Food intake was quantified by the 24-hour recall food diary
Measured: Baseline (Day 1) to Week 12
Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
The BACRI instrument is used to measure the benefit of weight gain treatment provided to anorexic patients on health related quality of life aspects. The scale is composed of 9 subscales (0 to 10 [worse to better]). The response was captured on a VAS scale in cm. The total BACRI score is the sum with a minimum score 0=worse and maximum score 90=better. These subscales are: change in weight impacting health; concern about weight; appearance change; change feeling of appearance; change in appetite; enjoy eating; overall feeling; benefit of treatment; and quality of life.
Measured: Baseline (Day 3) to Week 12
Appetite at Baseline (Day 3) and Week 12
Appetite was assessed via visual analogue scale (VAS) as part of the Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) (Question 5 only). The question was "To what extent has your appetite changed since the start of treatment?" The response was captured on a VAS scale in cm with a range from 0 ( "much worse") to 10 ("much better").
Measured: Baseline (Day 3) to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startDec 2004
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Jan Fourie, MD, Principal investigator, 58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637572
- Sponsor's protocol ID
- PAR-002
- Status last verified
- Sep 2017
- First submitted
- 11 Mar 2008
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-labeled, Pilot Study Comparing Weight Gain in Adults With AIDS-related Wasting Given Either Megestrol Acetate Oral Suspension Nanocrystal Dispersion (MA-NCD) or Megestrol Acetate Oral Suspension (Megace)
- ClinicalTrials.gov ID
- NCT00637572
- Acronym / sponsor ID
- PAR-002
- Conditions
- HIV Infections, Cachexia, Anorexia, AIDS Wasting Syndrome, HIV Wasting Syndrome
- Keywords
- Weight loss, Cachexia, Anorexia, Megestrol acetate oral suspension, Nanocrystal dispersion, Nanocrystal technology, Body weight changes, AIDS wasting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Dec 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Posted 20 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Megestrol acetate oral suspension nanocrystal dispersion | Experimental | Drug: Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mLMegestrol acetate oral suspension nanocrystal dispersion formulation 115 mg/mL |
| Megestrol acetate oral suspension micronized formulation | Active comparator | Drug: Megestrol acetate oral suspension 40 mg/mLMegestrol acetate oral suspension micronized formulation 60 mg/mL |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Capable of and willing to provide informed consent
- Evidence of HIV infection (either HIV-seropositive, CD4+ T-cell count of ≤350/mm3 or other clinically accepted indicator)
- An unintentional weight loss resulting in a weight 10% less than the lower limit of Ideal Body Weight for frame size, or a recent history of unintentional weight loss of 10% from the subjects baseline
- Weight losses was clinically associated with AIDS-related wasting and not related to any other disease process
- Women of childbearing potential had to agree to use effective contraception for the duration of the study and for two weeks after the last dose
Key exclusion criteria (13 listed)
- Weight loss due to factors other than AIDS-related wasting
- Enrollment in any other clinical trial
- Lack of access to regular meals
- Women of childbearing potential could not be pregnant or nursing
- Clinically severe depression evidenced by a baseline score of 17 or more on the Hamilton Depression Rating Scale (GRID-HAMD-17)
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 |
|---|---|---|
| Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mLAlso: Megace ESMegestrol acetate oral suspension nanocrystal dispersion 115 mg/mL administered as 575 mg once per day (5 mL dose) | Drug | Megestrol acetate oral suspension nanocrystal dispersion |
| Megestrol acetate oral suspension 40 mg/mLAlso: MegaceMegestrol acetate oral suspension 40 mg/mL administered as 800 mg once per day (20 mL dose) | Drug | Megestrol acetate oral suspension micronized formulation |
Primary outcome
Change in Body Weight
Time frame: Baseline (Day 1) to Week 12
Weight gain in adult HIV positive subjects who have weight loss with AIDS related wasting within the first 12 weeks of treatment
10 secondary outcomes
Change From Baseline in Lean Mass
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Impedance
Time frame: Baseline (Day 1) to Week 12
Change From Baseline in Body Fat Mass
Time frame: Baseline (Day 1) to Week 12
Change in Hip Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Waist Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Tricep Skinfold
Time frame: Baseline (Day 1) to Week 12
Change in Mid-arm Circumference
Time frame: Baseline (Day 1) to Week 12
Change in Total Energy
Time frame: Baseline (Day 1) to Week 12
Quality of Life (QoL) Via Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI) at Baseline (Day 3) and Week 12 (BACRI)
Time frame: Baseline (Day 3) to Week 12
Appetite at Baseline (Day 3) and Week 12
Time frame: Baseline (Day 3) to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationWanke C; Gutierrez J; Kristensen A; MacEarchern L. Safety and efficacy of two preparations of megestrol acetate in HIV-infected individuals with weight loss in Africa, India, and the United States. J Applied Res 2007;7(3):206-216
- Link to published studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jan Fourie, MD principal investigator
58 Ann Street, Dundee, KZ-Natal 3000, S. Africa
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Megestrol acetate oral suspension nanocrystal dispersion 115 mg/mL and Megestrol acetate oral suspension 40 mg/mL in people with HIV Infections and Cachexia, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in 3 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 12 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Africa, India, 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?
Yes. Results are posted in the registry (first posted 20 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Body Weight (time frame: Baseline (Day 1) to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637572, which also lists 1 linked publication.
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 5 Oct 2017.